Howida Kamal, Ph.D. Ass. Prof. of Pharmaceutics, Cairo University

Similar documents
Institute of Pharmaceutical Technololgy and Biopharmacy University of Pécs

At LATITUDE, we only do one thing, and we do it very well.

Design and Dosage Form. Dr. Deny Susanti

TASTE MASKING WITH COATINGS. Coating Technology 96 October 8-9, Presented by Ralph E. Pondell Corporate Secretary

CONTENTS SECTION I ESSENTIALS OF DOSAGE FORM DESIGN SECTION II SOLID DOSAGE FORMS CHAPTER 1 PREFORMULATION STUDIES CHAPTER 2 TABLETS.

INTRODUCTION TO INDUSTRIAL PHARMACY LAB 1

CHAPTER 1 PHARMACEUTICAL INDUSTRY

PHARMACEUTICAL MANUFACTURING

Formulation Development & CTM Manufacturing Services

Guidelines for Pharmaceutical Equivalence Requirements

University of Sulaimani College of Pharmacy Dept. of Pharmaceutics 5 th stage Second Semester

Formulations for clinical trials in children: possibilities and pitfalls? Robert Ancuceanu, PhD Member of PDCO and FWG

PETER GREVEN Your partner for pharmaceutical excipients

Approaches to the formulation of poorly soluble drugs

METHOCEL. TM Trademark of The Dow Chemical Company ( Dow ) or an affiliated company of Dow

DEVELOPMENT PHARMACEUTICS AND PROCESS VALIDATION

USP s Perspective on Drug Product Performance Test

ASEAN GUIDELINE ON STABILITY STUDY OF DRUG PRODUCT. Version 4.0. Update revision : May Document Control

Extractables & Leachables. Ophthalmic Drug Products: A Regulatory Perspective Current Industry Challenges and Case Studies

Orodispersible drug delivery systems

THE PHYSICAL CHARACTERISTICS OF LYOPHILIZED TABLETS CONTAINING A MODEL DRUG IN DIFFERENT CHEMICAL FORMS AND CONCENTRATIONS

Dynamic Future. Reliable Partnership. Company Profile of the Aenova Group

EVALUATION OF NEW FILM COATING PROCESSES AND MATERIALS

Rahavard Tamin Pharmaceutical Co. (RTPC)

Performance Testing of Novel Dosage Forms

How to Identify Critical Quality Attributes and Critical Process Parameters

THE DISSOLUTION PROCEDURE: DEVELOPMENT AND VALIDATION

Soluplus. Technical Information. October _090801e-01/Page 1 of 8. = Registered trademark of BASF group. Pharma Ingredients & Services

The Role of Compounded Medicines in Therapy. Loyd V. Allen, Jr., Ph.D.,R.Ph. Editor-in International Journal of Pharmaceutical Compounding

World Excipient Market

FOOD AND DRUGS AUTHORITY

Approval Review of Generic Drugs. Office of Generic/OTC Drugs, PMDA Kazuyuki SAITO, Ph.D.

Liquisolid Compacts Based Orodispersible Tablets to Enhance Solubility of Atorvastatin using Experimental Design

Design and Characterization of a Novel Sugar Free Formulation of Ferrous Gluconate in Oral Vial with Plunger and Tear Off Cap (VPTC)

1-6 Specifications. Andrew Chemwolo, Technical Officer, WHO Prequalification Team Medicines Assessment

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

EDQM Standard Terms. Internal controlled vocabularies for pharmaceutical dose forms. Version January 2018

Microbiological Consideration for Non-Sterile Pharmaceutical

Pharmaceutical Sciences

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS NOTE FOR GUIDANCE:

PQRI Research Project Proposal: Reporting and Qualification Thresholds for Leachables in Parenteral and Ophthalmic Drug Products

International Journal of Pharma and Bio Sciences IMPACT OF SOFT GELATIN CAPSULES FORMULATIONS FOR ORAL ADMINISTRATION ABSTRACT

CHAPTER 8: SOLID DOSAGE FORM COATING TECHNOLOGY NOOR MUHAMMAD SYAHRIN BIN YAHYA INTRODUCTION

Hermes_highlights_need_for_better_formats_OTCBulletin_ pdf. Published July Accessed July 10, 2016.

SUPAC OF IMMEDIATE-RELEASE, MODIFIED- RELEASE AND SEMI-SOLID: A REGULATORY NOTE

Meeting Solid Dose Formulation Challenges

Excipient Development at NCL

Dosage Form Design and Development

Golla and Rao, IJPSR, 2011; Vol. 2(10): ISSN:

Balancing the time, cost and risk of drug development. Christina Gustafsson, PhD Pharm, Formulation Scientist at Pharmaceutical Development, APL

MARIFARM LLC PRODUCTION ABOUT US

Evolution of Oil Where Did the Cutbacks Go? North Dakota Asphalt Conference 2019

Application as liquid carrier

Development of paediatric formulations - points to consider

ADVANTAGES OF MULTIPARTICULATES (PELLETS):

The science of transforming an Active Pharmaceutical Ingredient (API) into a Drug Product (DP) in a specific dosage form.

Tips & Hints for Quality Compounding - Part III

PHARMACEUTICAL EXCIPIENT MARKET OVERVIEW AND OUTLOOK

1201 Maryland Avenue SW, Suite 900, Washington, DC ,

TEPZZ A_T EP A1 (19) (11) EP A1. (12) EUROPEAN PATENT APPLICATION published in accordance with Art.

Modern Pharmaceutics. Second Edition, Revised and Expanded. edited by GILBERT S. BANKER University of Minnesota Minneapolis, Minnesota

Pharma Ingredients & Services. Ludiflash. Technical Information

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

Roller compactors for the pharmaceutical industry. BT 120 Pharma WP 120 Pharma WP 150 Pharma WP 200 Pharma

Pharma Ingredients & Services. Kollicoat IR White. Technical Information

Manufacture of Granulations Part 4. Industrial pharmacy 5 th class 1 st semester

Pharma Ingredients & Services. Ludiflash. Technical Information

ASEAN GUIDELINE ON STABILITY STUDY OF DRUG PRODUCT

Quality is Our Promise.

The Basics of Alkaline In-Process Cleaning. for Metal Substrates. John Sparks Oakite Products, Inc. Berkeley Heights, New Jersey

GUIDANCE DOCUMENT Use of a Foreign-sourced Reference Product as a Canadian Reference Product

Ensuring Quality Pharmacy Compounding: Implications for Pharmaceutics Education

QbD in developing semisolid formulations

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

USE OF SPHERICAL TECHNOLOGIES

Microfluidizer Processors:

3.2 Test for sterility

Adare Pharmaceuticals. A partnership that adds value to your products

MINISTRY OF HEALTH AND SOCIAL SERVICES

EMCOMPRESS. Calcium Hydrogen Phosphate, Ph.Eur., E 341(ii) Dibasic Calcium Phosphate, USP/NF, FCC. A Proven Excipient for more than 60 Years

Medicine Variations Guideline

Medicines Variations Guideline

"NOT FOR IMPLEMENTATION" GUIDANCE FOR INDUSTRY

Providing insight into pharmaceutical formulations

Preformulation. By: Ass. Prof. Gamal Shazly

Thermostable Biopharmaceuticals For Delivery Without Reconstitution

Blank Oral Rapid-Dissolve Tablets (Solid Suspension, 96 x 750 mg [0.93 ml] Tablets) Ingredient Listing Qty. Unit NDC # Supplier. 0.

TABLET COATING. Lec. 8

SIZE REDUCTION. Subject:Pharmaceutical Engineering Course:II B.Pharm I Sem Presented by Mr.C.Kishore M.Pharm(Pharmaceutics)

Technical Bulletin MC-25. Microcrystalline Cellulose

Asphalt is found in natural deposits in different parts of the world or as a product of the distillation of crude petroleum.

Kollicoat IR. The application of Kollicoat IR as a Zero Peroxide Binder for use in Solid Oral Dosage Forms. ExcipientFest.

Why Do I Test, What Do I Test & When Do I Test It? Ross Caputo, PhD Chief Technical Officer Eagle Analytical Services

INNOVATIVE COMPOUNDING SERVICES

Maximizing Roller Compaction Benefits with Proper Excipient Selection

Functionalized Calcium Carbonate (FCC) FCC: Newly developed structured minerals as multifunctional excipients

Q8 Pharmaceutical Development

WHITE PAPER: Amorphous Solid Dispersions-One approach to improving Bioavailability

Next Generation Pharma Solutions

Roles And Applications of Cellulose Ether in Environmentally Friendly. Building Materials

Transcription:

Howida Kamal, Ph.D Ass. Prof. of Pharmaceutics, Cairo University

Dosage forms Sterile Free from all forms of microbial life (vegetative & sporing) Free from pathogens Non-sterile Extent of total bioburden

Dosage forms Sterile Injections (parentrals) Ophthalmic Products Non-sterile All other routes of administration

Dosage forms Solid Liquid Semi-solid Powder Suppository Pessary Inserts Sponges Microparticles Nanoparticles Liposomes Films Solution Suspension Emulsion Microemulsion Nanoemulsion Nanosuspension In-situ gels Cream Ointment Paste Gel

Dosage forms Solid Liquid Semi-solid Advantages *Easy to use *Suitable for most routes of administration *Fast onset of action Disadvantages *Need for dose measurement *Short duration of action *Bulky to carry and store *Liability of drugs to degradation *Liable to microbial growth

Dosage forms Solid Liquid Semi-solid Advantages *Accurate dose *Easier to carry and store *More drug stability *No preservation requirements *Suitable for fast and extended drug release Disadvantages *Not for all routes of administration *Less convenient for administration for some patients *More complex and expensive manufacture

Liquid Dosage forms Solution Suspension Emulsion

Liquid Dosage forms Solution Suspension Emulsion Suspending agent O/W W/O

Liquid Dosage forms Solution Suspension Emulsion Deflocculated Flocculated

Liquid Dosage forms Solution Suspension Emulsion

Liquid Dosage forms Solution Suspension Emulsion Advantages *Dose uniformity *Easy to prepare *Suitable for all routes of adminstration *Fast onset of action *Easy to use Disadvantages *Not for insoluble drugs *Not for oral bitter drugs *Short duration of action *Bulky to carry *Liability of drugs to degradation *Need for dose measurement *Liable to microbial growth

Liquid Dosage forms Solution Suspension Emulsion Advantages *For insoluble drugs *For bitter drugs *Longer duration of action *Better chemical stability *Suitable for most routes of administration *Easy to use Disadvantages *Risk of dose variation *More difficult to prepare *Physical instability issues *Bulky to carry *Need for dose measurement *Liable to microbial growth

Liquid Dosage forms Solution Suspension Emulsion Advantages *For insoluble drugs *For bitter drugs *More chemical drug stability *Longer duration of action *Improved absorption *Suitable for most routes of administration *Easy to use Disadvantages *More difficult to prepare *Physical instability *Risk of rancidity *Bulky to carry *Need for dose measurement *Liable to microbial growth

Liquid Dosage forms Solution Excepients: Solvent Solubilizing agents Preservatives Antioxidants Buffer Sweetening agents Flavoring agents Coloring agent Suspension Excepients: Suspension medium Suspending agents Wetting agents Viscosity adjusters Preservatives Antioxidants Buffer Sweetening agents Coloring agent Emulsion Excepients: Aqueous solvent Oily phase Emulsifying agents Preservatives

Liquid Dosage forms Solution Suspension Emulsion Aqueous Non aqueous Oily Injections Hydroalcoholic Elixirs

Liquid Dosage forms Solution Suspension Emulsion Aqueous Oily

Liquid Dosage forms Solution Suspension Emulsion W/O O/W

Liquid Dosage forms Solution Suspension Emulsion Liquid Semi-solid Ointment Suppository

Liquid Dosage forms Solution Suspension Emulsion Liquid Semi-solid cream ointment

Solid Dosage forms Used as powder To be reconstituted Solution Suspension

Solid Dosage forms Bulk powder Divided powders

Solid Dosage forms Aggregates of powdered materials (2-4 mm) To be reconstituted

Solid Dosage forms Conventional release Controlled release Extended Delayed (enteric)

Solid Dosage forms

Solid Dosage forms

Solid Dosage forms Tablet Compression

Solid Dosage forms Multilayer tablets

Solid Dosage forms Coated tablets

Solid Dosage forms Coated tablets Sugar coat Film coat

Solid Dosage forms Conventional Orodispersible Chewable Soluble Effervescent Controlled release Extended Delayed (enteric)

Solid Dosage forms Hard gelatin Soft gelatin

Solid Dosage forms Hard gelatin Soft gelatin

Solid Dosage forms Conventional release Controlled release Extended Delayed (enteric)

Solid Dosage forms

Solid Dosage forms Rectal Vaginal (Pessaries) Urethral

Solid Dosage forms Dissolve Melt Disintegrate

Solid Dosage forms Advantages *Dissolve and disperse more readily *For bulk amounts of drugs *Accurate dose (divided) *Easier to carry and store *More drug stability *No preservation requirements Disadvantages *Poor flowability *Hygroscopic *Ability to cake *Not for all routes of administration

Solid Dosage forms Advantages *Good flowability *For large amounts of drugs *More stable against moisture and caking Disadvantages *Easier to be wetted *Not for all routes of *Accurate dose (divided) administration *Easier to carry and store *More drug stability, *No preservation requirements *Suitable for fast and extended drug release

Solid Dosage forms Advantages *Accurate dose *Easier to carry and store *More drug stability *No preservation requirements *Suitable for fast and extended drug release *Mask bad taste of drugs Disadvantages *Slow onset of action compared to liquids *Not for all routes of administration *Less convenient for administration for some patients

Solid Dosage forms Advantages *Faster action than tablets *Easier to swallow *For solid, semisolid and liquid drugs *Accurate dose, *More drug stability *Easier to carry and store *No preservation requirements *Suitable for fast and extended drug release *Mask bad taste of drugs Disadvantages

Solid Dosage forms Advantages Disadvantages *Slow onset of action compared to liquids *Not for all routes of administration *Less convenient for administration for some patients *More complex and expensive manufacture

Solid Dosage forms Excepients: Fillers (diluents) Lubricant Sweetening agents Flavoring agents Coloring agent

Solid Dosage forms Excepients: Fillers (diluents) Lubricant Binders Sweetening agents Flavoring agents Coloring agent

Solid Dosage forms Excepients: Fillers (diluents) Lubricant Binders Disintegrants Sweetening agents Flavoring agents Coloring agent

Solid Dosage forms Excepients: Fillers (diluents) Lubricant Sweetening agents Flavoring agents Coloring agent

Solid Dosage forms Cocoa butter Glycerinated gelatin Polyethylene glycol Surfactant

Semi-solid Dosage forms Cream Ointment Paste Gel W/O emulsion O/W emulsion

Semi-solid Dosage forms Cream Ointment Paste Gel Hydrocarbon base Absorption base Water removable base Water soluble base

Semi-solid Dosage forms Cream Ointment Paste Thicker, stiffer and less penetrating than ointments Gel aqueous fatty

Semi-solid Dosage forms Cream Ointment Paste Gel Organic macromolecules uniformly distributed in a liquid