Chronomodulated Delivery of Pantoprazole for Nocturnal Hyperacidity

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "Chronomodulated Delivery of Pantoprazole for Nocturnal Hyperacidity"

Transcription

1 3038 International J Pharm Journal Sci Nanotech of Pharmaceutical Vol 8; Issue Sciences 4 October and Nanotechnology December 2015 Research Paper Volume 8 Issue 4 October December 2015 MS ID: IJPSN MAHALAKSHMI Chronomodulated Delivery of Pantoprazole for Nocturnal Hyperacidity P. Mahalakshmi 1 *, T.N.K. Suriyaprakash 2 and S. Lakshmana Prabu 3 1,2 Department of Pharmaceutics, Al Shifa College of Pharmacy, Kerala , India; and 3 Department of Pharmaceutical Technology, Anna University of Technology, Tiruchirappalli , India. Received July 7, 2015; accepted August 13, 2015 ABSTRACT The objective of this work was to design and evaluate an oral site-specific, pulsatile drug delivery system containing Pantoprazole sodium which can be targeted to colon in a ph and time dependent manner, to modulate the drug level in synchrony with the circadian rhythm of nocturnal hyperacidity. Five different composition of Core tablets were prepared by direct compression technique. Based on the release studies of core tablets, nine different compositions of press coated tablets were prepared and analyzed. The press coated tablet further coated by using five different proportions of Eudragit RS PO for providing KEYWORDS: Pantoprazole; HPMC E15; Eudragit RS PO; Chronomodulated delivery; Circadian; Acidity. consistent, reproducible chronomodulated release profile. Formulation FPC3 is more suitable among the formulations to design pulsatile release formulations of pantoprazole sodium for 6 hours lag time. After this lag time burst release was observed which exhibited sigmodial release pattern and that was considered to be an ideal for the pulsatile drug delivery system. The chronomodulated drug delivery systems for pantoprazole sodium for the treatment of hyperacidity was successfully developed and the release of the drug was sharp and complete after the lag time which is necessary for any pulsatile drug delivery systems. Introduction The oral route of drug delivery is typically considered the favored and the most user-friendly means of drug administration having the highest degree of patient compliance, as a result of which much effort are aimed to identify orally active candidates that would provide reproducible and effective plasma concentration. (Saigal et al., 2009). All the functions in man are highly organized in time as biological rhythms of diverse periods, both in health and in disease. Several enzymatic activities, cellular detoxification and pharmacokinetics vary according to a 24 hr scale of the circadian rhythm (Qvortrup et al., 2010; Levi F 2002). Maintenance of constant drug level is not desirable for the optimal therapy. A drug should be delivered only when and where it is needed at the minimum required dose (Qureshi et al., 2008). This represents a challenge for those involved in the development of drug delivery systems to make possible the treatment of illness according to these physiological rhythms as a means of improving therapeutic outcomes. One approach is to increase the efficiency of pharmacotherapy for the administration of drugs at times at which they are most effective and best tolerated (Tiwari et al., 2008). The ability to deliver bioactive compounds to patients in a pulsatile release profile has been a major goal in drug delivery research over the last two decades. Based on the relevance of potential therapeutic applications, variety of design strategies have been formulated in the pursuit of pulsatile release (Anil et al., 2007). Biological rhythms not only impact the function of physiology, but also the pathophysiology of disease (Youan, 2004). The term Chrono refers to the observation that every metabolic event undergoes rhythmic changes in time. Chronotherapy is one of the several approaches to increase efficacy of chemotherapy has been investigated over years. In the chronotherapy, the drug delivery rate is adapted to the circadian rhythms which are endogenous and genetically based and measured along the 24 hr scale. Cellular rhythms can modulate the metabolism of cytotoxic agents and the cellular response to them (Granda TG et al., 2002; Raida et al., 2001). Chronopharmaceutics is clinically relevant, and reliable discipline could delineate a formal and systematic approach to design and evaluation drug delivery system that release a bioactive agents at a rhythm that ideally matches the biological requirements of a given disease therapy (Ohdo, 2010). A circumscribed inflammatory and often suppurating lesion on the skin or an internal mucous surface resulting in necrosis of tissue called ulcer. The proton pump inhibitors are a group of drugs that reduce the secretion of gastric acid, act by irreversibly binding with enzyme H +, K(+)-ATPase of the gastric parietal cells. This reduced secretion of acid in the stomach will aid in the healing of duodenal ulcers (Litalien et al., 2005). 3038

2 Mahalakshmi et al: Chronomodulated Delivery of Pantoprazole for Nocturnal Hyperacidity 3039 The objective of this work was to design and evaluate an oral site-specific, pulsatile drug delivery system containing Pantoprazole sodium which can be targeted to colon in a ph and time dependent manner, to modulate the drug level in synchrony with the circadian rhythm of nocturnal hyperacidity. Materials and Methods Materials Pantoprazole sodium and HPMC E15 were obtained as gift sample from Madras Pharmaceuticals, Chennai, India. Sodium chloride, Sodium bicarbonate, potassium dihydrogen ortho phosphate, microcrystalline cellulose, starch, gum acacia and talc were obtained from Nice Chemicals Pvt Ltd., Kochi, India. Magnesium stearate was obtained from Kemphasol, Mumbai, India; Isopropyl alcohol and PEG 4000 were obtained from Reachem Laboraotry Chemicals, Chennai, India; Eudragit RS PO from Sigma-Aldrich Cheme, Germany; Ethanol from Micro Fine Chemicals, Delhi, India and PVP from BASF Aktiengesellschaft, Germany. Methodology Formulation of core tablets: Five different composition of Core tablets were prepared by direct compression technique. Formulation composition is shown in Table 1. TABLE 1 Composition of pantoprazole sodium core formulation. Ingredients (mg) Formulation F1 F2 F3 F4 F5 Pantoprazole sodium Sodium chloride Micro crystalline cellulose Starch Sodium bicarbonate Magnesium strearate Talc Total weight Formulation of press coated tablets: Based on the release studies of core tablets, nine different compositions of press coated tablets were prepared in the ratio of 10%, 20% and 30% of drug: polymer with various binding agents. Press coated tablet compositions are shown in Table 2. TABLE 2 Composition of press coated tablet. Ingredients (mg) Formulation FP1 FP2 FP3 FP4 FP5 FP6 FP7 FP8 FP9 FP10 HPMC E Guar gum Acacia PVP in IPA PVP in hot water Development of pulsatile release tablets: The press coated tablet further coated by using five different proportions of Eudragit RS PO for providing consistent, reproducible chronomodulated release profile. TABLE 3 Coating composition. Ingredients (mg) Formulation FPC1 FPC2 FPC3 FPC4 FPC5 Eudragit RS PO PEG Talc q.s. q.s. q.s. q.s. q.s. Iso propyl alcohol 50 ml 50 ml 50 ml 50 ml 50 ml Drug-excipients compatibility studies: Excipients are integral components of almost all pharmaceutical dosage form. Compatibility studies are very important for the successful formulation of any dosage form. Commonly DSC, FT-IR, TLC and UV techniques are used for the determination of drug compatibility. Fourier Transform Infrared Spectroscopy (FTIR) and UV studies were used for the evaluation of physicochemical compatibility and interactions, which helps in the prediction of interaction of the drug with excipients used in the formulation. The earlier reports on drug-excipient interactions recommended that 1:1 ratio of drug and excipient maximizes the possibility of interaction and helps in easier detection of incompatibilities. (Lakshmana Prabu S et al., 2008). Therefore, in the present study 1:1 ratio was used for the preparation of physical mixtures and analyzed for compatibility studies. Fourier transform infrared spectroscopy: FTIR studies are very helpful in the evaluation of drug polymer interaction studies. Incompatibility between the drugs and excipients can be predicted based on their characteristic wave numbers. Drug and various polymers were thoroughly mixed with 300 mg of potassium bromide, compressed and the IR spectrum was obtained between 450 and 4000 cm -1 by placing the thin pellet in light path. Evaluation of tablet formulations (Bankar et al., (1987)) Evaluation of characteristics of powder blend and tablets: The various characteristics of powder blend like angle of repose, bulk density, tapped density, compressibility index, Hausner s ratio and drug content were studied. The formulated tablets were evaluated for uniformity of weight, hardness, friability, and drug content. The coated tablets were tested for Percentage weight gain, enteric coating test [USP Gastric Resistance test (Dissolution), Acid uptake testing (Disintegration)] and rupture test. In vitro dissolution studies: The dissolution studies were performed in triplicate for all the core tablets in a USP XXIII dissolution rate test apparatus (Type II) in phosphate buffer 6.8 for 3 minutes. To verify how the composition of the core and the barriers were interferes with the drug release profile form the cores, the in vitro release behavior of the uncoated cores and press-coated tablets, coated tablets were tested. Five milliliters aliquots were withdrawn at predefined intervals, and the volume of the dissolution medium was maintained by

3 3040 Int J Pharm Sci Nanotech Vol 8; Issue 4 October December 2015 adding the same volume of fresh prewarmed dissolution medium and the drug release was analyzed. Enteric Coating Test (USP) At the conclusion of the coating trials, chrono-modulated Pantoprazole sodium tablets were evaluated for: (a) USP Gastric Resistance test (Dissolution): The tablets were tested in a USP Dissolution apparatus (Basket type II) at 100 rpm using 0.1N HCl. The liberated Pantoprazole sodium was determined by means of UV- spectrophotometer (Schimadzu 1700). Failures in this case consisted of tablets that either disintegrated or had softened and become swollen. (b) Acid uptake testing (Disintegration): In this revised method, six coated tablets were weighed individually and placed in the disintegration basket tubes (Charles et al 2001). Immersed the disintegration basket in 900 ml of 0.1 N HCl and operated the apparatus for 2 hour. The individual tablets that were still intact then were dried with a towel and reweighed. The percent of weight increase was reported as % acid uptake. Tablets that fully disintegrated during the testing were counted as having 100% acid uptake. This method has been reported to provide an accurate measure of acid resistance of the coating, and acid uptake values, within 5% suggest that the tablets would readily pass the acid phase of the delayed-release dissolution testing. Rupture test (Jain et al,. 2010) The time at which the outer coating layer starts to rupture is defined as the lag time. It was determined visually by using the USP dissolution apparatus (Basket type II) 900 ml of 0.1 N HCl for initial 2 hour and then media was changed to phosphate buffer ph 6.8, 37±0.5 C, and 50 rpm. Effect of paddle speed on the lag time and release characteristics: Coated tablets were subjected to in vitro dissolution study at different paddle speeds (50 and 100 rpm) (Ali et al,. 2008). Effect of paddle speed on release behavior and lag time was observed and analyzed. SEM for optimized formulation: The tablet was transversely cut and sputtered with gold ion sputter coated under vacuum. Gold coated surface of tablet was evaluated by Hitachi PC based digital scanning electron microscope. Stability studies: The formulation which showed best in vitro release was selected for stability studies. The accelerated stability studies were conducted according to the ICH guidelines for a period of 6 months. Results and Discussion Drug delivery systems are becoming increasingly sophisticated as pharmaceutical scientists need to acquire a better understanding of the physicochemical and biological parameters pertaining to their performance. FT-IR and UV studies were performed to investigate chemical interactions between drug and the excipients. Pantoprazole sodium contains chemical functional groups like C-F stretching, C-O stretching, S=O stretching, C=C stretching, C=N stretching, C-O stretching, C-N stretching and C-H out of plane bending; the corresponding wave numbers are 3489, 1655, 1592, 1483, 1372, 1166, 1226 and 817 cm -1 respectively; these characteristic bands were present in the formulation composition. No new bands or shift in characteristic peaks were appeared. IR spectra are shown in Figure 1. In UV technique, the UV spectrum of drug is super impossible with the spectrum obtained with drug excipients mixtures and there is no change in the λmax 293 nm between the drug and drug excipients mixtures. FT-IR and UV results revealed that there is no interaction between the drug and the excipients used in the formulation. The formulated core tablets were evaluated for its physical properties like thickness, weight variation, hardness, friability, and content uniformity. The average weight of tablets were found to be between and g; hardness between 2.1 and 3.4 kg/m 2 ; friability between 0.42 and 0.87%; whereas the content uniformity was found to be and % w/w. All the tablets were found to pass the uniformity of weight. In vitro release studies were performed for 3 minutes and the release results are shown in Figure 2. Upon contact of the core tablet with the dissolution medium, the formulation releases CO2 that builds up the pressure within the tablet. The core erodes and ultimately explodes with immediate release of drug (surge release). At the end of 2.5 minutes F1 and F3 releases 99% of drug, but the hardness of F1 was not sufficient enough to withstand further press coating of tablets. So F3 was chosen as best formulation and used for press coating. F3 release pattern which were shown in Figure 3. Nine press coated formulations were prepared. The dried powder mixtures were tested for powder properties like angle of repose (between and ), bulk density (between 0.39 and 0.53 g/cc), tapped density (between 0.53 and 0.66 g/cc), percentage compressibility index (between and g/cc) and Hausner s ratio (between 1.15 and 1.25). The evaluation results revealed that all the powder mixture had good flow properties. The average weight of tablets were found to be between and g; hardness between 3.2 and 7.4 kg/m 2 ; friability between 0.56 and 0.927%; whereas the content uniformity was found to be and 99.43% w/w. All the tablets were found to pass the uniformity of weight. All the press coated tablets were subjected to dissolution study and the release results are shown in Figure 4 observed that all the formulations have shown reproducible drug release with distinct lag time. When compare to the other formulations, formulation FP6 had shown results in achieving a maximum of 99.6% drug release over a time period of 4 hours. The lag time of tablet decreased with increasing level of swelling layer.

4 Mahalakshmi et al: Chronomodulated Delivery of Pantoprazole for Nocturnal Hyperacidity 3041 As the amount of swelling agent increased, it exerted more pressure over the outer layer resulting in rapid rupturing of the tablet. From the above release studies press coated formulation FP6 was selected for enteric coating using Eudragit RS PO as the weight gain ratio of 3%, 5%, 7%, 8% and 10% w/w. The acid uptake test result shows that the 3% weight gain fails for the test; whereas other formulation passes for the acid uptake test results are shown in Table 4. Water uptake performance test was performed and the values were found to be between 20.31% and 23.35% w/w. In vitro release studies (Figure 5) were carried out for the coated tablets. Cumulative % drug release was observed before the lag time. The release was found to be 98.2% and 99.69%. The release before completion of lag time was found to be 99.27%, 98.02% and 98.22% for formulation FPC3, FPC4 and FPC5 respectively. Increasing the coating level of Eudragit RS PO shows a decrease in the dissolution rate of drug. This may be due to increasing the coat concentration made the coat more impermeable and drug release was retarded. As the coat ruptures slows, drug dissolution through it was facilitated. Thus this study clearly indicated that formulation FPC3 is more suitable among the formulations to design pulsatile release formulations of pantoprazole sodium for 6 hours lag time. After this lag time burst release was observed which exhibited sigmodial release pattern and that was considered to be an ideal for the pulsatile drug delivery system. Drug release from the device, need to be independent of agitation intensity of the release media. The cumulative percentage of drug released from the device was found to be 98.89% and 99.13% for 50 and 100 rpm respectively (Figure 6). The results revealed no drastic change in release profile in different rotational speed, as it predicts no change in the performance of the system as increased gastric motility. The SEM images clearly demonstrated the various layers core, inner swelling and outer polymer layer; which are shown in Figure 7a and 7b. Fig. 1. IR Spectra of drug, excipients and formulation composition.

5 3042 Int J Pharm Sci Nanotech Vol 8; Issue 4 October December 2015 Fig. 2. Comparative dissolution profile of core tablet formulation. Fig. 3. Release pattern of Pantoprazole sodium core. Fig. 4. Comparative dissolution profile of press coated tablet formulation. Fig. 5. Comparative dissolution profile of coated tablet formulation.

6 Mahalakshmi et al: Chronomodulated Delivery of Pantoprazole for Nocturnal Hyperacidity 3043 Fig. 6. Effect of paddle speed on the dissolution profile of optimized formulation. Fig. 7a. SEM of optimized formulation surface coated with Eduragit RS PO. Fig. 7b. SEM-Showing three layers. Stability studies were carried out at 40 C and 25 C and tested for its physical properties and in vitro release studies, stability study results revealed that the prepared formulation was stable in the stress condition. Conclusions The chronomodulated drug delivery system for pantoprazole sodium for the treatment of hyperacidity was successfully developed. The system was found to be

7 3044 Int J Pharm Sci Nanotech Vol 8; Issue 4 October December 2015 satisfactory interms of release of the drug after a lag time. The release of the drug was sharp and complete after the lag time which is necessary for any pulsatile drug delivery systems. References Anil KA (2007). Time controlled pulsatile drug delivery systems for bioactive compounds. Recent patents on drug delivery and formulation, 1: Bankar GS and Anderson GS (1987). Tablets. In: The theory and practice of industrial pharmacy (Lachman L, Liberman HA and Kanig JL eds), 3 rd ed. Varghese publishing house, Mumbai, p Cunningham CR and Fegely KA (2001). One-Step Aqueous Enteric Coating Systems: Scale-Up Evaluation. Pharmaceutical Technology, 5: Giacchetti S (2002). Chronotherapy of colorectal cancer, Chronobiology International, 9: Granda TG and Levi F (2002). Tumor-based rhythms of anticancer efficacy in experimental models. Chronobiology International, 19: Harris BE, Song R and Soong SJ (1990). Relationship between dihydropyrimidine dehydrogenase activity and plasma 5- fluorouracil levels with evidence for circadian variation of enzyme activity and plasma drug levels in cancer patients receiving 5-fluorouracil by protracted continuous infusion. Cancer Research, 50: Jain AK and Jain CP (2010). Effect of superdisintegrating agent and osmogens on ciprofloxacin loaded naturally occurring biodegradable coated tablets for colon targeting. International Journal of Pharmacy and Pharmaceutical Sciences, 2(4): Lakshmana Prabu S, Shnanawaz S and Dinesh Kumar C (2008). Compatibility studies between duloxetine hydrochloride and tablet excipients using thermal and non-thermal methods. J Pharm Research, 7(1): Levi F (2002). From circadian rhythms to cancer chronotherapeutics, Chronobiology International, 19: Litalien C and Faure C (2005). Pharmacokinetics of proton pump inhibitors in children. Clinical Pharmcokinetics, 44(5): Ohdo S (2010). Chromopharmaceutics: Pharmaceutics focused on biological rhythm. Biological Pharmaceutical Bulletin, 33(2): Ohdo S (2010). Chronopharmacology and chronotheraphy, Advanced drug Delivery Review, 62: Qureshi J, Amir M, Ahuja A, Baboota S and Ali J (2008). Chronomodulated drug delivery system of salbutamol sulphate for the treatment of nocturnal asthama. Indian Journal of Pharmaceutical Sciences, 70(3): Qvortrup C, Jensen BV, Fokstuen T, Nielsen SE, Keldsen N and Glimelius B (2010). A randomized study comparing short-time infusion of oxaliplatin in combination with capecitabine XELOX30 and chronomodulated XELOX30 as first-line therapy in patients with advanced colorectal cancer. Annals of Oncology 21: Raida M, Schwabe W, Hausler P, Van Kuilenburg AB, Van Gennip AH and Behnke D (2001). Prevalence of a common point mutation in the dihydropyrimidine dehydrogenase (DPD) gene within the 5 - splice donor site of intron 14 in patients with severe 5- fluorouracil (5-FU)-related toxicity compared with controls. Clinical Cancer Research, 7: Reppert SM and Weaver DR (2002). Coordination of circadian timing in mammals. Nature, 418: Saigal N, Baboota S, Ahuja A and Ali J (2009). Site specific chronotherapeutic drug delivery systems a patent review. Drug Delivery and Formulation, 3: Tiwari G (2010). Chronopharmaceutics: A clinically relevant approach to drug delivery. Research journal of pharmaceutical dosage forms and technology, 2(2): United States Pharmacopeia (USP-25/NF-28), Rockville, (MD2005). US Pharmacopeial Convention; : Youan BC (2004). Chronopharmaceutics: gimmick or clinically relevant approach to drug delivery, Journal of Controlled Release, 98: Address correspondence to: P.Mahalakshmi, Assistant Professor, Al Shifa College of Pharmacy, Poonthavanam Post, Kizhattur, Kerala , India. Tel: ;

Research Article. Formulation and in-vitro evaluation of orodispersible tablets of olanzapine for the improvement of dissolution rate

Research Article. Formulation and in-vitro evaluation of orodispersible tablets of olanzapine for the improvement of dissolution rate Available online www.jocpr.com Journal of Chemical and Pharmaceutical Research, 2016, 8(1):177-181 Research Article ISSN : 0975-7384 CODEN(USA) : JCPRC5 Formulation and in-vitro evaluation of orodispersible

More information

Formulation and in-vitro evaluation of pregabalin mini tablets for sustained release

Formulation and in-vitro evaluation of pregabalin mini tablets for sustained release Available online at www.scholarsresearchlibrary.com Scholars Research Library Der Pharmacia Lettre, 2016, 8 (2):277-283 (http://scholarsresearchlibrary.com/archive.html) ISSN 0975-5071 USA CODEN: DPLEB4

More information

Formulation and in vitro evaluation of bosentan osmatic controlled release tablets

Formulation and in vitro evaluation of bosentan osmatic controlled release tablets IJPAR Vol.4 Issue 4 Oct- Dec -2015 Journal Home page: ISSN: 2320-2831 Research article Open Access Formulation and in vitro evaluation of bosentan osmatic controlled release tablets Mohammed Asif Hussain,

More information

Kollidon SR: A polyvinyl acetate based excipient for DCsustained-release

Kollidon SR: A polyvinyl acetate based excipient for DCsustained-release Kollidon SR: A polyvinyl acetate based excipient for DCsustained-release oral dosage forms by Dr. Bernhard Fussnegger BASF Aktiengesellschaft, Ludwigshafen Strategic Marketing Pharma Excipients Introduction

More information

Rajesh Kaza. et al /J. Pharm. Sci. & Res. Vol.1(4), 2009,

Rajesh Kaza. et al /J. Pharm. Sci. & Res. Vol.1(4), 2009, Design and Evaluation of Sustained release Floating tablets for the treatment of Gastric Ulcers Rajesh Kaza* 1, E. Usharani 2, R.Nagaraju 2, R.Haribabu 3 and P.V.Siva Reddy 4 1* Sree Vidyanikethan College

More information

INTERNATIONAL JOURNAL OF PHARMACY & LIFE SCIENCES

INTERNATIONAL JOURNAL OF PHARMACY & LIFE SCIENCES INTERNATIONAL JOURNAL OF PHARMACY & LIFE SCIENCES Effect of various polymers on swelling and in vitro release of ramipril in effervescent system Sudheer Nadendla*,Snehalatha, T.S.Nagaraja and Bharathi

More information

RAJASHREE S. MASAREDDY*, GUPTA ALOKNATH L, DANISH KURIEN

RAJASHREE S. MASAREDDY*, GUPTA ALOKNATH L, DANISH KURIEN Academic Sciences Asian Journal of Pharmaceutical and Clinical Research Vol 4, Suppl 2, 2 ISSN - 974-244 Research Article DEVELOPMENT AND CHARACTERIZATION OF DILTIAZEM HYDROCHLORIDE PULSATILE DRUG DELIVERY

More information

"NOT FOR IMPLEMENTATION" GUIDANCE FOR INDUSTRY

NOT FOR IMPLEMENTATION GUIDANCE FOR INDUSTRY "NOT FOR IMPLEMENTATION" GUIDANCE FOR INDUSTRY Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo

More information

RESEARCH ARTICLE e-issn:

RESEARCH ARTICLE e-issn: Available online at www.ijtpls.com International Journal of Trends in Pharmacy and Life Sciences Vol. 2, Issue: 2, 2016: 801-812. FORMULATION AND EVALUATION OF FLOATING DRUG DELIVERY SYSTEM OF ENALAPRIL

More information

Asian Journal of Pharmaceutical and Clinical Research Vol. 3, Issue 4, 2010 ISSN

Asian Journal of Pharmaceutical and Clinical Research Vol. 3, Issue 4, 2010 ISSN Asian Journal of Pharmaceutical and Clinical Research Vol. 3, Issue 4, 2010 ISSN - 0974-2441 Research Article A STUDY ON THE EFFECT OF DIFFERENT CELLULOSE POLYMERS ON RELEASE RATE FROM TRAMADOL LOADED

More information

FORMULATION AND EVALUATION OF ACECLOFENAC MATRIX TABLETS FOR COLON DRUG DELIVERY

FORMULATION AND EVALUATION OF ACECLOFENAC MATRIX TABLETS FOR COLON DRUG DELIVERY ISSN:2230-7346 Research Article Available online http://www.jgtps.com Journal of Global Trends in Pharmaceutical Sciences Vol.1, Issue 1, pp 53-60, Oct Dec 2010 FORMULATION AND EVALUATION OF ACECLOFENAC

More information

Table 1. Particle size distributions and peroxide levels of various superdisintegrants. D50 (μm) D10 (μm)

Table 1. Particle size distributions and peroxide levels of various superdisintegrants. D50 (μm) D10 (μm) PHARMACEUTICAL TECHNOLOGY REPORT Consumer Specialties ashland.com PTR-97 Page 1 of 5 Utility of Polyplasdone crospovidone as a Superdisintegrant Quyen Schwing, Marvin Davis, Divya Tewari, Thomas Dürig

More information

INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH AND BIO-SCIENCE DESIGN AND DEVELOPMENT OF FLOATING PULSATILE DRUG DELIVERY SYSTEM USING MELOXICAM

INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH AND BIO-SCIENCE DESIGN AND DEVELOPMENT OF FLOATING PULSATILE DRUG DELIVERY SYSTEM USING MELOXICAM Sunil Patel,, 2012: Volume1 (2): 215-235 RESEARCH ARTICLE INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH AND BIO-SCIENCE A Path for Horizing Your Innovative Work DESIGN AND DEVELOPMENT OF FLOATING PULSATILE

More information

Application of Quality by Design (QbD) in product development. James E. Polli September 16, 2015

Application of Quality by Design (QbD) in product development. James E. Polli September 16, 2015 Application of Quality by Design (QbD) in product development James E. Polli jpolli@rx.umaryland.edu September 16, 2015 Pharmaceutical Equivalence Same active ingredient(s) Same dosage form Same route

More information

Excipient Development at NCL

Excipient Development at NCL New Reverse Enteric Polymer for Oral Dosage Forms Excipient Development at omplete Solution for Taste Masking Moisture Barrier Sustained Release Immediate Release Polymorphism Inhibition National hemical

More information

FORMULATION AND EVALUATION OF PRESS COATED TABLET OF KETOPROFEN A CHRONOTHERAPEUTIC APPROACH

FORMULATION AND EVALUATION OF PRESS COATED TABLET OF KETOPROFEN A CHRONOTHERAPEUTIC APPROACH Academic Sciences International Journal of Pharmacy and Pharmaceutical Sciences ISSN- 0975-1491 Vol 5, Suppl 3, 2013 Research Article FORMULATION AND EVALUATION OF PRESS COATED TABLET OF KETOPROFEN A CHRONOTHERAPEUTIC

More information

Formulation and In-Vitro Evaluation of Sustained Release Tablet of Isosorbide -5- Mononitrate by Porous Osmotic Technology

Formulation and In-Vitro Evaluation of Sustained Release Tablet of Isosorbide -5- Mononitrate by Porous Osmotic Technology Online Available at www.thepharmajournal.com THE PHARMA INNOVATION Formulation and In-Vitro Evaluation of Sustained Release Tablet of -5- by Porous Osmotic Technology Margret chandira 1*, S. Shanthi 1,

More information

International Journal of Chemistry and Pharmaceutical Sciences. International Journal of Chemistry and Pharmaceutical Sciences

International Journal of Chemistry and Pharmaceutical Sciences. International Journal of Chemistry and Pharmaceutical Sciences B. Venkateswara Reddy, IJCPS, 2015, 3(2): 1537 1543 ISSN: 2321-3132 International Journal of Chemistry and Pharmaceutical Sciences Journal Home Page: www.pharmaresearchlibrary.com/ijcps Research Article

More information

Pelagia Research Library. Design fabrication and characterization of controlled released tablets of Trimetazidine di hydrochloride

Pelagia Research Library. Design fabrication and characterization of controlled released tablets of Trimetazidine di hydrochloride Available online at www.pelagiaresearchlibrary.com Der Pharmacia Sinica, 2011, 2 (6):59-66 ISSN: 0976-8688 CODEN (USA): PSHIBD Design fabrication and characterization of controlled released tablets of

More information

Pelagia Research Library

Pelagia Research Library Available online at www.pelagiaresearchlibrary.com Der Pharmacia Sinica, 2012, 3 (5):598-603 ISSN: 0976-8688 CODEN (USA): PSHIBD Formulation and evaluation of solid matrix tablets of repaglinide Jitender

More information

FORMULATION AND EVALUATION OF POLYMER EFFECT ON in-vitro KINETICS OF SUSTAINED RELEASE MATRIX TABLETS OF CARVEDILOL USING MODEL DEPENDENT METHODS

FORMULATION AND EVALUATION OF POLYMER EFFECT ON in-vitro KINETICS OF SUSTAINED RELEASE MATRIX TABLETS OF CARVEDILOL USING MODEL DEPENDENT METHODS FORMULATION AND EVALUATION OF POLYMER EFFECT ON in-vitro KINETICS OF SUSTAINED RELEASE MATRIX TABLETS OF CARVEDILOL USING MODEL DEPENDENT METHODS Umme Rahela, Md. Mizanur Rahman Moghal *, Syed Masudur

More information

Effect of Hydrophobic Polymers on the Gastro Retention Time and In vitro Release of Ciprofloxacin HCl from Co-matrix Tablets

Effect of Hydrophobic Polymers on the Gastro Retention Time and In vitro Release of Ciprofloxacin HCl from Co-matrix Tablets Effect of Hydrophobic Polymers on the Gastro Retention Time and In vitro Release of Ciprofloxacin HCl from Co-matrix Tablets Muhammad Shahidul Islam 1, Kumar Bishwajit Sutradhar 2, Jakir Ahmed Chowdhury

More information

World Journal of Pharmacy and Biotechnology. World Journal of Pharmacy and Biotechnology

World Journal of Pharmacy and Biotechnology. World Journal of Pharmacy and Biotechnology Angilicam Avinash et al, WJPBT, 2016, 3(1): 01 06 ISSN: 2349-9087 World Journal of Pharmacy and Biotechnology Journal Home Page: www.pharmaresearchlibrary.com/wjpbt Research Article Open Access Design,

More information

Formulation and Evaluation of Oro-Dispersible Tablets Containing Meclizine Hydrochloride

Formulation and Evaluation of Oro-Dispersible Tablets Containing Meclizine Hydrochloride Int. J. Pharm. Sci. Rev. Res., 42(2), January - February 17; Article No. 10, Pages: 47-52 Research Article Formulation and Evaluation of Oro-Dispersible Tablets Containing Meclizine Hydrochloride Rakhee

More information

NISSO HPC for Pharmaceutical Applications

NISSO HPC for Pharmaceutical Applications NISSO HPC for Pharmaceutical Applications Contents Introduction Features of NISSO HPC Major Application of NISSO HPC NISSO HPC Grades and Availability How to use based on Application and Features of NISSO

More information

Formulation Design and Optimization of an Enteric Coated Sustained Release Mucoadhesive Tablet of Metronidazole

Formulation Design and Optimization of an Enteric Coated Sustained Release Mucoadhesive Tablet of Metronidazole International Journal of PharmTech Research CODEN (USA): IJPRIF ISSN : 0974-4304 Vol.2, No.2, pp 1269-1275, April-June 2010 Formulation Design and Optimization of an Enteric Coated Sustained Release Mucoadhesive

More information

Quality by Design for ANDAs: An Example for Immediate-Release Dosage Forms

Quality by Design for ANDAs: An Example for Immediate-Release Dosage Forms Quality by Design for ANDAs: An Example for Immediate-Release Dosage Forms Introduction to the Example This is an example pharmaceutical development report illustrating how ANDA applicants can move toward

More information

Design and Evaluation of Sustained Release Tablets containing Solid dispersion of Ziprasidone hydrochloride

Design and Evaluation of Sustained Release Tablets containing Solid dispersion of Ziprasidone hydrochloride International Journal of PharmTech Research CODEN (USA): IJPRIF ISSN : 0974-4304 Vol.6, No.3, pp 959-968, July-Aug 2014 Design and Evaluation of Sustained Release Tablets containing Solid dispersion of

More information

Direct compression of cushion layered ethyl cellulose coated extended release pellets into rapidly disintegrating tablets

Direct compression of cushion layered ethyl cellulose coated extended release pellets into rapidly disintegrating tablets Research Article ISSN: 0974-6943 M.Yasmin Begum et al. / Journal of Pharmacy Research 2016,10(1), Available online through http://jprsolutions.info Direct compression of cushion layered ethyl cellulose

More information

Drug exhibiting absorption from only a. Design and Clinical Evaluation of Floating Mini Matrix Tablets of Pyridoxine Hydrochloride ORIGINAL ARTICLE

Drug exhibiting absorption from only a. Design and Clinical Evaluation of Floating Mini Matrix Tablets of Pyridoxine Hydrochloride ORIGINAL ARTICLE ORIGINAL ARTICLE Design and Clinical Evaluation of Floating Mini Matrix Tablets of Pyridoxine Hydrochloride Kiran Kumar 1, P. Srikanth 1, M. Ajitha 2, Y. Madhusudan Rao 1 1 Department of Pharmaceutics,

More information

Formulation and Evaluation of Chronotherapeutic Pulsatile Drug Delivery System Containing Rabeprazole Sodium

Formulation and Evaluation of Chronotherapeutic Pulsatile Drug Delivery System Containing Rabeprazole Sodium Journal of Applied Pharmaceutical Science Vol. 7 (02), pp. 093-100, February, 2017 Available online at http://www.japsonline.com DOI: 10.7324/JAPS.2017.70211 ISSN 2231-3354 Formulation and Evaluation of

More information

Formulation And Evaluation Of Esomeprazole Magnesium Controlled Release Multiple Unit Matrix Pellets By Extrusion And Spheronization Technology

Formulation And Evaluation Of Esomeprazole Magnesium Controlled Release Multiple Unit Matrix Pellets By Extrusion And Spheronization Technology Formulation And Evaluation Of Esomeprazole Magnesium Controlled Release Multiple Unit Matrix Pellets By Extrusion And Spheronization Technology K. Selvaraju KSG. Arulkumaran KMCH College of Pharmacy, Coimbatore,

More information

THE PHARMA INNOVATION - JOURNAL Formulation and Development of Floating and Mucoadhesive Microspheres of Clarithromycin

THE PHARMA INNOVATION - JOURNAL Formulation and Development of Floating and Mucoadhesive Microspheres of Clarithromycin Received: 07-05-2013 Accepted: 09-06-2013 ISSN: 2277-7695 CODEN Code: PIHNBQ ZDB-Number: 2663038-2 IC Journal No: 7725 Vol. 2 No. 5 2013 Online Available at www.thepharmajournal.com THE PHARMA INNOVATION

More information

Research Article. Quality by Design (QbD) Approach for Formulation Development of Hydralazine Hydrochloride Tablets

Research Article. Quality by Design (QbD) Approach for Formulation Development of Hydralazine Hydrochloride Tablets Available online www.jocpr.com Journal of Chemical and Pharmaceutical Research, 2016, 8(5):336-341 Research Article ISSN : 0975-7384 CODEN(USA) : JCPRC5 Quality by Design (QbD) Approach for Formulation

More information

Design and Evaluation of a new Capsule-type Dosage form for Colon-Targeted Delivery of Etoricoxib

Design and Evaluation of a new Capsule-type Dosage form for Colon-Targeted Delivery of Etoricoxib International Journal of Pharma Sciences Vol. 3, No. 1 (2013): 147-151 Research Article Open Access ISSN: 2249-8214 Design and Evaluation of a new Capsule-type Dosage form for Colon-Targeted Delivery of

More information

Method Development and Validation for Online UV-Dissolution Methods Using Fiber-Optic Technology

Method Development and Validation for Online UV-Dissolution Methods Using Fiber-Optic Technology Technical Overview Method Development and Validation for Online UV-Dissolution Methods Using Fiber-Optic Technology Introduction Online fiber-optic and multicell UV-dissolution systems have become increasingly

More information

PHARMACEUTICAL TECHNOLOGY REPORT. Introduction. Experimental Methods

PHARMACEUTICAL TECHNOLOGY REPORT. Introduction. Experimental Methods PHARMACEUTICAL TECHNOLOGY REPORT Consumer Specialties ashland.com PTR-079 Page 1 of 5 Advantages of Hot Melt Extrusion for the Controlled Release of High Doses of Highly Soluble Actives E. Pinto, H. Yang,

More information

Formulation Design and Development of Mucoadhesive Tablets of Cefixime Trihydrate

Formulation Design and Development of Mucoadhesive Tablets of Cefixime Trihydrate Formulation Design and Development of Mucoadhesive Tablets of Cefixime Trihydrate Ansari Afaque Raza Mehboob*, Patil Ravikant Yashwantrao, Waghmode Chetan Satish, Shinde Ashalata Sudhakar Department of

More information

Recent FDA Guidance For Industry; BCS Class 1 and 3 August 2015

Recent FDA Guidance For Industry; BCS Class 1 and 3 August 2015 Recent FDA Guidance For Industry; BCS Class 1 and 3 August 2015 Bryan Crist Scientific Affairs Manager, Agilent Technologies, Dissolution Systems Dissolution Exchange WebEx Bryan.crist@agilent.com August,

More information

Formulation Development and Polymer Optimization for Once-Daily Sustained Release Matrix Tablets of Domperidone

Formulation Development and Polymer Optimization for Once-Daily Sustained Release Matrix Tablets of Domperidone Journal of PharmaSciTech 20; ():283 Research Article Formulation Development and Polymer Optimization for OnceDaily Sustained Release Matrix Tablets of Domperidone Department of Pharmacy,Annamalai University,Annamalainagar

More information

Pharma & Food Solutions. ETHOCEL One of the Few Water-Insoluble Polymers Approved for Global Pharmaceutical Applications

Pharma & Food Solutions. ETHOCEL One of the Few Water-Insoluble Polymers Approved for Global Pharmaceutical Applications Pharma & Food Solutions ETHOCEL One of the Few Water-Insoluble Polymers Approved for Global Pharmaceutical Applications ETHOCEL Premium Polymers are essentially tasteless, colorless, odorless, noncaloric

More information

Process validation of clopidogrel bisulphate 75 mg tablets

Process validation of clopidogrel bisulphate 75 mg tablets Available online at www.scholarsresearchlibrary.com Scholars Research Library Der Pharmacia Lettre, 2014, 6 (3):72-78 (http://scholarsresearchlibrary.com/archive.html) ISSN 0975-5071 USA CODEN: DPLEB4

More information

Design and Evaluation of Pulsatile Drug Delivery of Losartan Potassium

Design and Evaluation of Pulsatile Drug Delivery of Losartan Potassium Design and Evaluation of Pulsatile Drug Delivery of Losartan Potassium M.S. Ashwini 1 and Mohammed Gulzar Ahmed 2 1 Department of Pharmaceutics, Sri Adichunchanagiri College of Pharmacy, Karnataka -571448

More information

Pelagia Research Library. Formulation and evaluation of fast dissolving sublingual tablets of amlodipine besylate

Pelagia Research Library. Formulation and evaluation of fast dissolving sublingual tablets of amlodipine besylate Available online at www.pelagiaresearchlibrary.com Der Pharmacia Sinica, 2014, 5(4):1-9 ISSN: 0976-8688 CODEN (USA): PSHIBD Formulation and evaluation of fast dissolving sublingual tablets of amlodipine

More information

FORMULATION AND EVALUATION OF ALFUZOSIN HYDROCHLORIDE EXTENDED RELEASE TABLETS

FORMULATION AND EVALUATION OF ALFUZOSIN HYDROCHLORIDE EXTENDED RELEASE TABLETS JChrDD Vol 2 Issue 1 2011: 43-48 ISSN: 2249-6785 Journal of Chronotherapy and Drug Delivery Received: Nov 12, 2010 Revised: Dec 16, 2010 Accepted: May 5, 2011 Original Research Paper FORMULATION AND EVALUATION

More information

BRITISH BIOMEDICAL BULLETIN

BRITISH BIOMEDICAL BULLETIN Journal Home Page www.bbbulletin.org BRITISH BIOMEDICAL BULLETIN Original Formulation and In vitro Evaluation of Metoprolol Succinate Extended Release Pellets Ch.Kalyani 1*, K. Veer Reddy 1, E.Anka Rao

More information

Formulation & Evaluation of Sustained Release Mucoadhesive Buccal Patch of Pantoprazole

Formulation & Evaluation of Sustained Release Mucoadhesive Buccal Patch of Pantoprazole Research Article ISSN: 0976-5700 Formulation & Evaluation of Sustained Release Mucoadhesive Buccal Patch of Pantoprazole Elsheikh Tajelsir, Aisha Khanum Department of Pharmaceutics, Al-Ameen college of

More information

COMPARATIVE EVALUATION OF TASTE MASKING METHODS OF ONDANSETRON HCl

COMPARATIVE EVALUATION OF TASTE MASKING METHODS OF ONDANSETRON HCl WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES Bhalekar et al. SJIF Impact Factor 2.786 Volume 3, Issue 8, 982-995. Research Article ISSN 2278 4357 COMPARATIVE EVALUATION OF TASTE MASKING METHODS

More information

EFFERVESCENT BIOADHESIVE VAGINAL TABLET OF METRONIDAZOLE FOR BACTERIAL VAGINOSIS - DESIGN AND IN-VITRO EVALUATION

EFFERVESCENT BIOADHESIVE VAGINAL TABLET OF METRONIDAZOLE FOR BACTERIAL VAGINOSIS - DESIGN AND IN-VITRO EVALUATION IJPSR (2014), Vol. 5, Issue 9 (Research Article) Received on 03 March, 2014; received in revised form, 07 May, 2014; accepted, 26 June, 2014; published 01 September, 2014 EFFERVESCENT BIOADHESIVE VAGINAL

More information

DIRECTLY COMPRESSIBLE MEDICATED CHEWING GUM (MCG) FOR STAYING ALERT

DIRECTLY COMPRESSIBLE MEDICATED CHEWING GUM (MCG) FOR STAYING ALERT DIRECTLY COMPRESSIBLE MEDICATED CHEWING GUM (MCG) FOR STAYING ALERT July 2012 Introduction Medicated chewing gums are defined by the European Pharmacopoeia 1 and the guidelines for pharmaceutical dosage

More information

Microcrystalline Cellulose, Colloidal Silicon Dioxide, Sodium Starch Glycolate, Sodium Stearyl Fumarate

Microcrystalline Cellulose, Colloidal Silicon Dioxide, Sodium Starch Glycolate, Sodium Stearyl Fumarate Microcrystalline Cellulose, Colloidal Silicon Dioxide, Sodium Starch Glycolate, Sodium Stearyl Fumarate Ready-to-Use High Functionality Excipient Composite Offering Advantages for Total Cost Savings Superior

More information

Design and Development of Polyethylene Oxide Based Matrix Tablets for Verapamil Hydrochloride

Design and Development of Polyethylene Oxide Based Matrix Tablets for Verapamil Hydrochloride Research Paper Design and Development of Polyethylene Oxide Based Matrix Tablets for Verapamil Hydrochloride S. VIDYADHARA, R. L. C. SASIDHAR* AND R. NAGARAJU 1 Department of Pharmaceutics, Chebrolu Hanumaiah

More information

Fabrication and in vitro evaluation of Venlafaxine Hydrochloride mini tablets filled hard Gelatin Capsules

Fabrication and in vitro evaluation of Venlafaxine Hydrochloride mini tablets filled hard Gelatin Capsules Research Article www.pharmaresearchlibrary.com/ijctpr ISSN: 2321-376 International Journal of Current Trends in Pharmaceutical Research IJCTPR, 213: Vol. 1(3): 161-168 Fabrication and in vitro evaluation

More information

Design and Dosage Form. Dr. Deny Susanti

Design and Dosage Form. Dr. Deny Susanti Design and Dosage Form Dr. Deny Susanti Example 1 Aspirin tablet is stable but not as a liquid dosage form How to design liquid form? Soluble or dispersible aspirin tablets-to be dissolved in water Note:

More information

Assistant professor of Pharmaceutics and Pharmaceutical Technology, College of Pharmacy, Taibah University, Madina, Saudi Arabia.

Assistant professor of Pharmaceutics and Pharmaceutical Technology, College of Pharmacy, Taibah University, Madina, Saudi Arabia. Journal of Applied Pharmaceutical Science Vol. 6 (09), pp. 063-068, September, 2016 Available online at http://www.japsonline.com DOI: 10.7324/JAPS.2016.60909 ISSN 2231-3354 In-vitro bioequivalence, physicochemical

More information

QbD implementation in Generic Industry: Overview and Case-Study

QbD implementation in Generic Industry: Overview and Case-Study QbD implementation in Generic Industry: Overview and Case-Study Inna Ben-Anat, QbD Strategy Leader, Teva Pharmaceuticals IFPAC JAN 2013 R&D Three Core Components of QbD and Generic Industry: How Do They

More information

Formulation, Evaluation and Optimization of Fast dissolving tablet containing Tizanidine Hydrochloride

Formulation, Evaluation and Optimization of Fast dissolving tablet containing Tizanidine Hydrochloride International Journal of PharmTech Research ISSN : 0974-4304 Vol.1,No.1,pp 34-42, Jan March 2009 Formulation, Evaluation and Optimization of Fast dissolving tablet containing Tizanidine Hydrochloride P.S.

More information

Design and Characterization of Enteric Coated Delayed Release Pellets of Rabeprazole Sodium

Design and Characterization of Enteric Coated Delayed Release Pellets of Rabeprazole Sodium American Journal of Advanced Drug Delivery www.ajadd.co.uk Design and Characterization of Enteric Coated Delayed Release Pellets of Rabeprazole Sodium Y. Surekha*, P. Venugopalaiah, K. Gnan Prakash and

More information

Parthiban Kakkatummal Nishad and Natesan Senthil Kumar

Parthiban Kakkatummal Nishad and Natesan Senthil Kumar International Journal of PharmTech Research CODEN (USA): IJPRIF ISSN : 0974-4304 Vol.2, No.3, pp 1775-1780, July-Sept 2010 Formulation and Evaluation of Sustained Release Tablets of Aceclofenac using Hydrophilic

More information

COLONIC DRUG DELIVERY SYSTEM OF TRIMETAZIDINE HYDROCHLORIDE FOR ANGINA PECTORIS

COLONIC DRUG DELIVERY SYSTEM OF TRIMETAZIDINE HYDROCHLORIDE FOR ANGINA PECTORIS International Journal of Pharmacy and Pharmaceutical Sciences ISSN- 975-1491 Vol 3, Issue 2, 211 Research Article COLONIC DRUG DELIVERY SYSTEM OF TRIMETAZIDINE HYDROCHLORIDE FOR ANGINA PECTORIS ANIL KUMAR.S.N

More information

Formulation and Evaluation of Ora-Solv Tablets of Pantoprazole Sodium

Formulation and Evaluation of Ora-Solv Tablets of Pantoprazole Sodium and Evaluation of Ora-Solv Tablets of Pantoprazole Sodium N.Jawahar*, Sumeet Sood, Kunal Jain and M.Barath Department of Pharmaceutics, J.S.S. College of Pharmacy, Ooty, Tamilnadu-643001, India. Abstract

More information

Formulation and evaluation of ibuprofen pulsin cap technique for controlled release

Formulation and evaluation of ibuprofen pulsin cap technique for controlled release Available online at www.scholarsresearchlibrary.com Scholars Research Library Der Pharmacia Lettre, 2013, 5 (1):60-68 (http://scholarsresearchlibrary.com/archive.html) ISSN 0975-5071 USA CODEN: DPLEB4

More information

Characterization of Drug and Polymers for Development of Colon Specific Drug Delivery System

Characterization of Drug and Polymers for Development of Colon Specific Drug Delivery System Page17 e-issn: 2249-622X RESEARCH ARTICLE Characterization of Drug and Polymers for Development of Colon Specific Drug Delivery System 1. Nandgude Tanaji D. 1*, Bhise Kiran S. 2 Research Scholar, Department

More information

OPTIMIZATION OF OLANZAPINE MOUTH DISSOLVING TABLETS USING MICRONIZATION

OPTIMIZATION OF OLANZAPINE MOUTH DISSOLVING TABLETS USING MICRONIZATION Page384 Research Article Pharmaceutical Sciences OPTIMIZATION OF OLANZAPINE MOUTH DISSOLVING TABLETS USING MICRONIZATION Raja Sridhar Rao. P a * & G. Chandrasekara Rao b a Department of Pharmaceutics,

More information

Design and development of floating In-Situ gel of pantoprazole

Design and development of floating In-Situ gel of pantoprazole Available online at www.scholarsresearchlibrary.com Scholars Research Library Der Pharmacia Lettre, 2016, 8 (8):239-249 (http://scholarsresearchlibrary.com/archive.html) ISSN 0975-5071 USA CODEN: DPLEB4

More information

International Journal of Research in Pharmaceutical and Nano Sciences Journal homepage:

International Journal of Research in Pharmaceutical and Nano Sciences Journal homepage: Research Article CODEN: IJRPJK ISSN: 2319 9563 International Journal of Research in Pharmaceutical and Nano Sciences Journal homepage: www.ijrpns.com FORMULATION AND EVALUATION OF ORO DISPERSIBLE TABLETS

More information

Model-based Technology Selection for Bioavailability Enhancement CPHI DAVID K. LYON, PH.D. OCTOBER 25, 2017

Model-based Technology Selection for Bioavailability Enhancement CPHI DAVID K. LYON, PH.D. OCTOBER 25, 2017 Model-based Technology Selection for Bioavailability Enhancement CPHI DAVID K. LYON, PH.D. OCTOBER 25, 2017 Biopharmaceutical Classification System Approximately 80% of drugs in the pharmaceutical compounds

More information

PM Vasanth et al. IRJP 2012, 3 (12) INTERNATIONAL RESEARCH JOURNAL OF PHARMACY

PM Vasanth et al. IRJP 2012, 3 (12) INTERNATIONAL RESEARCH JOURNAL OF PHARMACY PM Vasanth et al. IRJP 212, 3 (12) INTERNATIONAL RESEARCH JOURNAL OF PHARMACY www.irjponline.com ISSN 223 847 Research Article FORMULATION AND IN-VITRO EVALUATION OF EFFERVESCENT FLOATING MATRIX TABLETS

More information

SUSTAINED RELEASE From Coated Ion Exchange Resins. H.S. Hall Coating Place, Inc. Verona, WI 53593

SUSTAINED RELEASE From Coated Ion Exchange Resins. H.S. Hall Coating Place, Inc. Verona, WI 53593 SUSTAINED RELEASE From Coated Ion Exchange Resins 79-1 by H.S. Hall Coating Place, Inc. Verona, WI 53593 A substantial amount of work has been published concerning the use of ion exchange resins for sustained

More information

FORMULATION AND EVALUATION OF SUSTAINED RELEASE MATRIX TABLETS OF AMBROXOL HYDROCHLORIDE USING NATURAL POLYMER

FORMULATION AND EVALUATION OF SUSTAINED RELEASE MATRIX TABLETS OF AMBROXOL HYDROCHLORIDE USING NATURAL POLYMER IJPSR (2014), Vol. 5, Issue 10 (Research Article) Received on 19 March, 2014; received in revised form, 19 May, 2014; accepted, 05 July, 2014; published 01 October, 2014 FORMULATION AND EVALUATION OF SUSTAINED

More information

Development and Evaluation of Floating Drug Delivery System of Chlorothiazide

Development and Evaluation of Floating Drug Delivery System of Chlorothiazide Human Journals Research Article August 2016 Vol.:7, Issue:1 All rights are reserved by SHINKAR DATTATRAYA MANOHAR et al. Development and Evaluation of Floating Drug Delivery System of Chlorothiazide Keywords:

More information

RapidFACT: Accelerated Formulation Development for Poorly Soluble Drugs and Modified Release Products

RapidFACT: Accelerated Formulation Development for Poorly Soluble Drugs and Modified Release Products RapidFACT: Accelerated Formulation Development for Poorly Soluble Drugs and Modified Release Products Kevin Kane, Scientific Director, BCP 7 th Annual Global Drug Delivery & Formulation Summit 28 th August

More information

DESIGN DEVELOPMENT AND EVALUATION OF MATRIX TABLETS OF AMBROXOL HYDROCHLORIDE: IN VITRO IN VIVO STUDY

DESIGN DEVELOPMENT AND EVALUATION OF MATRIX TABLETS OF AMBROXOL HYDROCHLORIDE: IN VITRO IN VIVO STUDY Innovare Academic Sciences International Journal of Pharmacy and Pharmaceutical Sciences ISSN- 0975-1491 Vol 6, Issue 6, 2014 Original Article DESIGN DEVELOPMENT AND EVALUATION OF MATRIX TABLETS OF AMBROXOL

More information

Design, evaluation and optimization of fluconazole trandermal patch by 2 2 factorial method

Design, evaluation and optimization of fluconazole trandermal patch by 2 2 factorial method Available online at www.scholarsresearchlibrary.com Scholars Research Library Der Pharmacia Lettre, 2016, 8 (5):280-287 (http://scholarsresearchlibrary.com/archive.html) ISSN 0975-5071 USA CODEN: DPLEB4

More information

RESEARCH ARTICLE e-issn:

RESEARCH ARTICLE e-issn: Available online at www.ijtpls.com International Journal of Trends in Pharmacy and Life Sciences Vol. 1, Issue: 4, 215: 457-47 FORMULATION AND IN-VITRO EVALUATION OF IVABRADINE BUCCAL TABLETS Garika Swapna*,

More information

Pharma Ingredients & Services. Ludiflash. Technical Information

Pharma Ingredients & Services. Ludiflash. Technical Information Technical Information Ludiflash March 2012 Supersedes issue dated August 2011 03_070805e-03/Page 1 of 10 = Registered trademark of BASF group Excipient for fast-disintegrating oral dosage forms Direct

More information

Formulation and Optimization of Taste Masked Rapimelt Dolasteron Mesylate Tablets

Formulation and Optimization of Taste Masked Rapimelt Dolasteron Mesylate Tablets ARC Journal of Pharmaceutical Sciences (AJPS) Volume 1, Issue 1, June 2015, PP 5-13 www.arcjournals.org Formulation and Optimization of Taste Masked Rapimelt Dolasteron Mesylate Tablets Parasuram Rajam

More information

FORMULATION AND EVALUATION OF ORODISPERSIBLE TABLETS OF METOPROLOL TARTRATE WITH NATURAL AND SYNTHETIC SUPERDISINTEGRANTS

FORMULATION AND EVALUATION OF ORODISPERSIBLE TABLETS OF METOPROLOL TARTRATE WITH NATURAL AND SYNTHETIC SUPERDISINTEGRANTS Academic Sciences International Journal of Pharmacy and Pharmaceutical Sciences ISSN- 0975-1491 Vol 4, Issue 3, 2012 Research Article FORMULATION AND EVALUATION OF ORODISPERSIBLE TABLETS OF METOPROLOL

More information

One-Step Aqueous Enteric Coating Systems: Scale-Up Evaluation

One-Step Aqueous Enteric Coating Systems: Scale-Up Evaluation One-Step Aqueous Enteric Coating Systems: Scale-Up Evaluation Charles R. Cunningham* and Kurt A. Fegely Two aqueous enteric coating systems, poly(vinyl acetate) phthalate based Sureteric and acrylicbased

More information

Formulation of Acetylsalicylic Acid Tablets for Aqueous Enteric Film Coating

Formulation of Acetylsalicylic Acid Tablets for Aqueous Enteric Film Coating Formulation of cetylsalicylic cid Tablets for queous Enteric Film Coating Charles R. Cunningham,* Bruce R. Kinsey, and Laura K. Scattergood COLORCON The goal of this study was to determine which combination

More information

Public Assessment Report Scientific discussion. Clindamycin Actavis (clindamycin hydrochloride) SE/H/1538/001-02/DC

Public Assessment Report Scientific discussion. Clindamycin Actavis (clindamycin hydrochloride) SE/H/1538/001-02/DC Public Assessment Report Scientific discussion Clindamycin Actavis (clindamycin hydrochloride) SE/H/1538/001-02/DC This module reflects the scientific discussion for the approval of Clindamycin Actavis

More information

Delayed Release Formulation of Pantoprazole Using Sureteric Aqueous Dispersion System

Delayed Release Formulation of Pantoprazole Using Sureteric Aqueous Dispersion System Available online at www.scholarsresearchlibrary.com Scholars Research Library Der Pharmacia Lettre, 2013, 5 (5):175-186 (http://scholarsresearchlibrary.com/archive.html) ISSN 0975-5071 USA CODEN: DPLEB4

More information

Abstract. Technical Aspects. Applying GastroPlus for Extensions of Biowaivers for BCS Class II Compounds 2

Abstract. Technical Aspects. Applying GastroPlus for Extensions of Biowaivers for BCS Class II Compounds 2 Abstract GastroPlus is a mechanistically based simulation software package that predicts absorption, pharmacokinetics, and pharmacodynamics in humans and animals. GastroPlus modeling and simulation has

More information

How to Identify Critical Quality Attributes and Critical Process Parameters

How to Identify Critical Quality Attributes and Critical Process Parameters How to Identify Critical Quality Attributes and Critical Process Parameters Jennifer Maguire, Ph.D. Daniel Peng, Ph.D. Office of Process and Facility (OPF) OPQ/CDER/FDA FDA/PQRI 2 nd Conference North Bethesda,

More information

Innovations in Pharmaceuticals and Pharmacotherapy

Innovations in Pharmaceuticals and Pharmacotherapy Innovations in Pharmaceuticals and Pharmacotherapy eissn: 2321 323X pissn: 2395-0781 www.innpharmacotherapy.com Research article Design and evaluation of floating gastro retentive tablets of fixed dose

More information

Formulation And Evaluation Of Compression Coated Tablets Of Cefpodoxime Proxetil

Formulation And Evaluation Of Compression Coated Tablets Of Cefpodoxime Proxetil Formulation And Evaluation Of Compression Coated Tablets Of Cefpodoxime Proxetil Ms. Nandini.D.Banerjee*, Mrs. Sushma R. Singh. (Dr.L.H.Hiranandani college of Pharmacy, CHM Campus, Ulhasnagar- 03, Maharashtra.)

More information

International Journal of Medicine and Pharmaceutical Research. International Journal of Medicine and Pharmaceutical Research

International Journal of Medicine and Pharmaceutical Research. International Journal of Medicine and Pharmaceutical Research A. Surekha et al, IJMPR, 2015, 3(1): 924 931 ISSN: 2321-2624 International Journal of Medicine and Pharmaceutical Research Journal Home Page: www.pharmaresearchlibrary.com/ijmpr Research Article Open Access

More information

EUROPEAN JOURNAL OF European PHARMACEUTICAL. Journal of Pharmaceutical and Medical Research AND MEDICAL RESEARCH.

EUROPEAN JOURNAL OF European PHARMACEUTICAL. Journal of Pharmaceutical and Medical Research AND MEDICAL RESEARCH. ejpmr, 2017,4(10), 450-454 SJIF Impact Factor 4.161 Research Article EUROPEAN JOURNAL OF European PHARMACEUTICAL Journal of Pharmaceutical and Medical Research AND MEDICAL RESEARCH ISSN 2394-3211 www.ejpmr.com

More information

OSDrC OptiDose : A Revolution in Drug Formulation Technology

OSDrC OptiDose : A Revolution in Drug Formulation Technology Review Article OSDrC OptiDose : A Revolution in Drug Formulation Technology Sayantany Chandra*, Sayantan Sadhukhan, Sabyasachi Maiti, Somasree Ray Department of Pharmaceutics, Gupta College of Technological

More information

Research Article PREPARATION AND IN VITRO EVALUATION OF HYDROXY PROPYL METHYLCELLULOSE FILMS FOR TRANSDERMAL DELIVERY OF SERTRALINE HYDROCHLORIDE

Research Article PREPARATION AND IN VITRO EVALUATION OF HYDROXY PROPYL METHYLCELLULOSE FILMS FOR TRANSDERMAL DELIVERY OF SERTRALINE HYDROCHLORIDE International Journal of Research and Development in Pharmacy and Life Sciences Available online at http//www.ijrdpl.com June - July, 2015, Vol. 4, No.4, pp 1673-1678 ISSN (P): 2393-932X, ISSN (E): 2278-0238

More information

Supporting Information. Low temperature synthesis of silicon carbide nanomaterials using

Supporting Information. Low temperature synthesis of silicon carbide nanomaterials using Supporting Information Low temperature synthesis of silicon carbide nanomaterials using solid-state method Mita Dasog, Larissa F. Smith, Tapas K. Purkait and Jonathan G. C. Veinot * Department of Chemistry,

More information

INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH AND BIO-SCIENCE

INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH AND BIO-SCIENCE Ravneet Kaur,, 2012: Volume1 (2):94-101 ISSN: 2277-8713 RESEARCH ARTICLE INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH AND BIO-SCIENCE A Path for Horizing Your Innovative Work EXPLORATION OF DIFFERENT

More information

Validated Stability-indicating assay method for determination of Ilaprazole in bulk drug and tablets by high performance liquid chromatography

Validated Stability-indicating assay method for determination of Ilaprazole in bulk drug and tablets by high performance liquid chromatography Validated Stability-indicating assay method for determination of Ilaprazole in bulk drug and tablets by high performance liquid chromatography Pradeep G. Shelke a*, Anil V. Chandewar a, Anil P. Dewani

More information

Studies in Prospective Process Validation of Gliclazide Tablet 80 mg Dosage Formulation

Studies in Prospective Process Validation of Gliclazide Tablet 80 mg Dosage Formulation International Journal of PharmTech Research CODEN (USA): IJPRIF ISSN : 0974-4304 Vol.3, No.3,pp 1515-1520, July-Sept 2011 Studies in Prospective Process Validation of Gliclazide Tablet 80 mg Dosage Formulation

More information

Drug Development: Why Does it Cost so Much? Lewis J. Smith, MD Professor of Medicine Director, Center for Clinical Research Associate VP for Research

Drug Development: Why Does it Cost so Much? Lewis J. Smith, MD Professor of Medicine Director, Center for Clinical Research Associate VP for Research Drug Development: Why Does it Cost so Much? Lewis J. Smith, MD Professor of Medicine Director, Center for Clinical Research Associate VP for Research Drug Development Process by which new chemical entities

More information

Formulation and Evaluation of Simvastatin Rapidmelts

Formulation and Evaluation of Simvastatin Rapidmelts Human Journals Research Article August 2016 Vol.:7, Issue:1 All rights are reserved by T. Neelima Rani et al. Formulation and Evaluation of Simvastatin Rapidmelts Keywords: Simvastatin, β-cyclodextrin,

More information

RESEARCH ARTICLE e-issn:

RESEARCH ARTICLE e-issn: 1 2 3 Available online at www.ijtpls.com International Journal of Trends in Pharmacy and Life Sciences Vol. 3, Issue: 4, 2017: 55-66. FORMULATION AND IN VITRO EVALUATION OF LIQUI SOLID 5 COMPACT OF FELODIPINE

More information

Implementing Quality by Design Principles and Concepts to Drug Delivery and Formulation Development. S Betterman 15Apr2015

Implementing Quality by Design Principles and Concepts to Drug Delivery and Formulation Development. S Betterman 15Apr2015 Implementing Quality by Design Principles and Concepts to Drug Delivery and Formulation Development S Betterman 15Apr2015 Agenda Background Implementation Strategy Infrastructure Building Project Application

More information

BCS Guidance and Biowaivers BCS Monographs

BCS Guidance and Biowaivers BCS Monographs BCS Guidance and Biowaivers BCS Monographs Vinod P. Shah, Ph.D., Pharmaceutical Consultant PQRI Board Member 2 nd FDA/PQRI Conference on Advancing Product Quality Emerging Regulatory Initiatives Biopharmaceutics

More information

TABLETABILITY, COMPACTABILITY, AND COMPRESSIBILTY: WHAT S THE DIFFERENCE?

TABLETABILITY, COMPACTABILITY, AND COMPRESSIBILTY: WHAT S THE DIFFERENCE? WHITEPAPER TABLETABILITY, COMPACTABILITY, AND COMPRESSIBILTY: WHAT S THE DIFFERENCE? { To patients and consumers, tablets are a simple and convenient dosage form. But the science behind compressing a block

More information