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The Pharmaceutical Industry takes responsibility for the formulation of a drug product which is physically and chemically stable, manufacturable, and bioavailable. The problem is that most drugs undergo structural polymorphism, and it is preferable to
develop the most thermodynamically stable polymorph of the drug to assure reproducible bioavailability of the product over its shelf-life under a variety of real world storage conditions. For this assignment you are required to choose a suitable
drug candidate from the list provided. In this assignment after a general introduction on polymorphism, you should provide a detailed profile on your chosen drug candidate ( including analytical methodology and sampling procedures are in place which assure that a problem will be detected before dosage forms which have compromised quality or bioavailability can reach patients) and then conclude by highlighting the effect of polymorphic transformation on the quality of the drug
product and the bioavailability of the drug substance, including the impact on clinical
outcomes for patients.
Drug Candidates:
• Ranitidine
• Carbamazepine
• Theophylline
• Mebendazole
• Rifampicin
• Paracetamol (Acetaminophen)
Reference:
Advanced Drug Delivery Reviews 2004, Vol 56 (3) 235-418 Pharmaceutical solid polymorphism in drug development and regulation - Special Edition.
Your assignment should be no more than ten A4 pages in length in an appropriate font size 11 with 1.5 line spacing. References in Vancouver style.
The Pharmaceutical Industry takes responsibility for the formulation of a drug product which is physically and chemically stable, manufacturable, and bioavailable. The problem is that most drugs undergo structural polymorphism, and it is preferable to
develop the most thermodynamically stable polymorph of the drug to assure reproducible bioavailability of the product over its shelf-life under a variety of real world storage conditions. For this assignment you are required to choose a suitable
drug candidate from the list provided. In this assignment after a general introduction on polymorphism, you should provide a detailed profile on your chosen drug candidate ( including analytical methodology and sampling procedures are in place which assure that a problem will be detected before dosage forms which have compromised quality or bioavailability can reach patients) and then conclude by highlighting the effect of polymorphic transformation on the quality of the drug
product and the bioavailability of the drug substance, including the impact on clinical
outcomes for patients.
Drug Candidates:
• Ranitidine
• Carbamazepine
• Theophylline
• Mebendazole
• Rifampicin
• Paracetamol (Acetaminophen)
Reference:
Advanced Drug Delivery Reviews 2004, Vol 56 (3) 235-418 Pharmaceutical solid polymorphism in drug development and regulation - Special Edition.
Your assignment should be no more than ten A4 pages in length in an appropriate font size 11 with 1.5 line spacing. References in Vancouver style.
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