PURPOSE: This commentary is intended to provide a scientific perspective on pharmaceutical solid polymorphism in Abbreviated New Drug Applications (ANDAs). METHODS: This report proposes recommendations for monitoring and controlling drug substance polymorphs and describes scientific considerations of pharmaceutical solid polymorphism in the determination of drug substance sameness. RESULTS: It presents three decision trees for solid oral dosage forms or liquids containing undissolved drug substances to provide a process for evaluating when and how polymorphs of drug substances are monitored and controlled in ANDA submissions. CONCLUSIONS: It is scientifically concluded that differences in polymorphic composition of drug substances in generic drug products and reference-listed drugs are not directly relevant in the determination of drug substance sameness in ANDAs.
PURPOSE: This commentary is intended to provide a scientific perspective on pharmaceutical solid polymorphism in Abbreviated New Drug Applications (ANDAs). METHODS: This report proposes recommendations for monitoring and controlling drug substance polymorphs and describes scientific considerations of pharmaceutical solid polymorphism in the determination of drug substance sameness. RESULTS: It presents three decision trees for solid oral dosage forms or liquids containing undissolved drug substances to provide a process for evaluating when and how polymorphs of drug substances are monitored and controlled in ANDA submissions. CONCLUSIONS: It is scientifically concluded that differences in polymorphic composition of drug substances in generic drug products and reference-listed drugs are not directly relevant in the determination of drug substance sameness in ANDAs.
Authors: Olga I Vernaya; Andrey N Ryabev; Tatyana I Shabatina; Daria L Karlova; Andrey V Shabatin; Lyudmila N Bulatnikova; Alexander M Semenov; Mikhail Ya Melnikov; Vladimir I Lozinsky Journal: Polymers (Basel) Date: 2022-08-11 Impact factor: 4.967
Authors: Hannes Lengauer; Damjan Makuc; Damjan Šterk; Franc Perdih; Arthur Pichler; Tina Trdan Lušin; Janez Plavec; Zdenko Časar Journal: Pharmaceutics Date: 2020-04-10 Impact factor: 6.321