Podcast
Questions and Answers
Pharmaceutical formulationPharmaceutics CH4417 Lecture 3 Dr Sarah Hudson [email protected] MS2-019, Dept. of Chemical Sciences, SSPC, Bernal Institute Active Pharmaceutical Ingredients Small Molecule versus large Biomolecules They differ in terms of the following (but it is API dependent): Primary Manufacturing Secondary Manufacturing Dosage Forms Routes of administration Cost Generics/Biosimilars Manufacturing Processes Manufacturing of Small Molecule Active Pharmaceutical Ingredients expensive products and raw materials yield and purity most important small productions often batch processes often agitated tanks – 1 – 10 m3 multipurpose, multiproduct plants flexibility quick process development batch integrity tradition Production campaigns ≥10 days Value of one batch. Cleaning Increasing interest into continuous manufacturing systems. InTech-Anaerobic treatment of industrial effluents an overview of applications Common Unit Operations Filtration Mixing Solvent Extraction Distillation Centrifugation Grinding pH adjustment Washing Carbon treatment (adsorption) Crystallization/precipitation Drying Continuous Manufacturing https://www.lilly.com/our-medicines/manufacturing-quality/for-better-lives Sau Lee. J. Pharm Innov (2015) 10:191-199.
Pharmaceutical formulationPharmaceutics CH4417 Lecture 3 Dr Sarah Hudson [email protected] MS2-019, Dept. of Chemical Sciences, SSPC, Bernal Institute Active Pharmaceutical Ingredients Small Molecule versus large Biomolecules They differ in terms of the following (but it is API dependent): Primary Manufacturing Secondary Manufacturing Dosage Forms Routes of administration Cost Generics/Biosimilars Manufacturing Processes Manufacturing of Small Molecule Active Pharmaceutical Ingredients expensive products and raw materials yield and purity most important small productions often batch processes often agitated tanks – 1 – 10 m3 multipurpose, multiproduct plants flexibility quick process development batch integrity tradition Production campaigns ≥10 days Value of one batch. Cleaning Increasing interest into continuous manufacturing systems. InTech-Anaerobic treatment of industrial effluents an overview of applications Common Unit Operations Filtration Mixing Solvent Extraction Distillation Centrifugation Grinding pH adjustment Washing Carbon treatment (adsorption) Crystallization/precipitation Drying Continuous Manufacturing https://www.lilly.com/our-medicines/manufacturing-quality/for-better-lives Sau Lee. J. Pharm Innov (2015) 10:191-199.
Flashcards
Small Molecule API Manufacturing
Small Molecule API Manufacturing
The production of small molecule APIs involves expensive raw materials, prioritizes yield and purity, often uses batch processes in agitated tanks (1-10 m3), and occurs in multipurpose plants. Continuous manufacturing systems are of increasing interest.
