Cream Formulation 1 KA U S A R A H M A D KU L L I Y YA H O F P H A R M A C Y http://staff.iium.edu.my/akausar PHM4153 Dosage Design 2 2011/12 Contents 2 Ideal formulati on PHM4153 Dosage Design 2 2011/12
Types of excipient s Propertie s Examples of Creams 3 Whitenin g Benzophenone, hydroquinone Fruit extracts
Antiageing Collagen, seaweed extract Liposome Virility Fish Herbs PHM4153 Dosage Design 2 2011/12 Formulation 4 Process whereby drugs are combined
with other substances (excipients) e.g. preservative to produce dosage forms e.g. cream suitable for administration to or by patients. PHM4153 Dosage Design 2 2011/12 Ideal formulation 5 Non-irritant Nonallergenic
Non-staining Easy to apply Pleasant feeling to the skin Non-toxic Non-harmful Incapable of microorganis m growth Free from
side-effects PHM4153 Dosage Design 2 2011/12 Formulation requirement: efficacy, safety, and quality 6 Contain accurate dose Convenient to take or administer Retain quality throughout
shelf life & usage period PHM4153 Dosage Design 2 2011/12 Provide drug in a form for absorption or other delivery to the target Manufactured by a process that does not compromise performance and that is reproducible and economical
Factors to be considered in formulation 7 Physicochemical properties Choice of vehicle Waxes and oils or emulsions Categories of excipients Provide essential part of the dosage form Prevent degradation of the formulation Stability PHM4153 Dosage Design 2 2011/12 Choice of vehicle 8
Bases from mixtures of low and high MW PEG Liposomes Multiple emulsions PHM4153 Dosage Design 2 2011/12 Microemulsio ns Fluorocarbon emulsions
PHM4153 Dosage Design 2 2011/12 effect Little barrier effect Varying stability against oxidation Good absorption Good delivery expensive Excipients 14 Other components other than API added to formulation PHM4153 Dosage Design 2 2011/12
Categories of excipients 15 Provide essential parts of dosage form & enhance bioavailability Emulsifiers Viscosity modifier Prevent degradation of the formulation: protect, improve safety & enhance stability Anti-oxidants Anti-bacterials Preservatives UV absorbers Aid processing during manufacturing Assist product identification colour PHM4153 Dosage Design 2 2011/12
Choosing excipients 16 physiological inertness commercially available at low cost physical and chemical stability absence of pathogenic microbial organisms
conformance to regulatory agency requirements no interference with drug bioavailability PHM4153 Dosage Design 2 2011/12 Emulsifiers 17 w/o o/w PHM4153 Dosage Design 2 2011/12
Penetration enhancers 18 Increase delivery of active substance by: Disturb packing of SC lipid bilayer Examples: surfactants Disruption of skin barrier Extraction of skin lipids with apolar solvents e.g. acetone Physical stripping Physically or chemically induced irritation PHM4153 Dosage Design 2 2011/12 Hydration
19 Hygroscopic effect NaCl Sorbitol PPG glycerol PHM4153 Dosage Design 2 2011/12 Alter waterbinding capacity of corneocytes Low MW glycerol s
Q. How does urea moisturise the skin? 20 PHM4153 Dosage Design 2 2011/12 21 PHM4153 Dosage Design 2 2011/12 pH adjustment 22 Triethanolamine NaoH PHM4153 Dosage Design 2 2011/12
PHM4153 Dosage Design 2 2011/12 Elomet cream 0.1% Mometasone furoate White petrolatum White wax PPG stearate Stearyl alcohol Ceteareth-20 Hexylene glycol Titanium dioxide Al starch octenylsuccinate Purified water Phosphoric acid
References 37 Bugay, D. E. (1999). Pharmaceutical excipients : characterization by IR, Raman, and NMR spectroscopy. RS201E87B931P Kibbe, A. H. (2000). Handbook of pharmaceutical excipients. RS201E87H236K Rowe, R. C., Sheskey, P. J. & Owen, S. C. (2006). Handbook of pharmaceutical excipients RS201E87H236K Rowe, R. C. (2009). Handbook of pharmaceutical excipients. RS201E87H236K PHM4153 Dosage Design 2 2011/12 38
Some materials sourced from the following: http://www.eastman.com/Markets/Pharmaceutical/Excipients/Excipients_in tro.asp http://www.pharmaceutical-technology.com/contractors/materials/uniqema/ http://www.pformulate.com/ http://images.vertmarkets.com/CRLive/files/Downloads/89FB7970-7376-44 A0-B6B6-4B171E4B978B/InsolubleKollidon.pdf Thank you to contributors. PHM4153 Dosage Design 2 2011/12
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