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

Transcription

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

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

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

4 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

5 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

6 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

7 Liquid Dosage forms Solution Suspension Emulsion

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

9 Liquid Dosage forms Solution Suspension Emulsion Deflocculated Flocculated

10 Liquid Dosage forms Solution Suspension Emulsion

11 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

12 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

13 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

14 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

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

16 Liquid Dosage forms Solution Suspension Emulsion Aqueous Oily

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

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

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

20 Solid Dosage forms Used as powder To be reconstituted Solution Suspension

21 Solid Dosage forms Bulk powder Divided powders

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

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

24 Solid Dosage forms

25 Solid Dosage forms

26 Solid Dosage forms Tablet Compression

27 Solid Dosage forms Multilayer tablets

28 Solid Dosage forms Coated tablets

29 Solid Dosage forms Coated tablets Sugar coat Film coat

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

31 Solid Dosage forms Hard gelatin Soft gelatin

32 Solid Dosage forms Hard gelatin Soft gelatin

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

34 Solid Dosage forms

35 Solid Dosage forms Rectal Vaginal (Pessaries) Urethral

36 Solid Dosage forms Dissolve Melt Disintegrate

37 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

38 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

39 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

40 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

41 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

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

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

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

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

46 Solid Dosage forms Cocoa butter Glycerinated gelatin Polyethylene glycol Surfactant

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

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

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

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