PILOT PLANT SCALE UP TECHNIQUES （试验厂规模技术）.ppt

Formulation aspects of oral liquids Suspensions: Purpose Agent Facilitating the connection between API and vehicle -wetting agents Salt formation ingredients Protecting the API - Buffering-systems, polymers, antioxidants Maintaining the suspension appearance Colorings, suspending agent, flocculating agent. Masking the unpleasant taste/smell Sweeteners, flavorings 23 August 2012 * KLE College of Pharmacy, Nipani. Emulsions: Purpose Agent Particle Size Solid particles, Droplet particles Protecting the API Buffering-systems, antioxidants, polymers Maintaining the appearance Colorings, Emulsifying agents, Penetration enhancers, gelling agents Taste/smell masking Sweetners, flavorings 23 August 2012 * KLE College of Pharmacy, Nipani. Formulation aspects of oral liquids Solutions: Protecting the API Buffers, antioxidants, preservatives Maintaining the appearance Colorings, stabilizers, cosolvents, antimicrobial preservatives Taste/smell masking Sweetners, flavorings. 23 August 2012 * KLE College of Pharmacy, Nipani. Formulation aspects of oral liquids Layout of the pilot plant 23 August 2012 * KLE College of Pharmacy, Nipani. Equipments Mixer Homogenizer Filteration assembly Bottling assembly 23 August 2012 * KLE College of Pharmacy, Nipani. Filtration assembly 23 August 2012 * KLE College of Pharmacy, Nipani. General flow chart Raw Materials Measured and weighed Mixing Filling Packing Distilled water Finished products storage Quality Assurance 23 August 2012 * KLE College of Pharmacy, Nipani. Quality assurance Dissolution of drugs in solution Potency of drugs in suspension Temperature uniformity in emulsions Microbiological control Product uniformity Final volume Stability 23 August 2012 * KLE College of Pharmacy, Nipani. References Lachman L. The Theory and practice of industrial pharmacy. 3rd Edition. Varghese publication house. 23 August 2012 * KLE College of Pharmacy, Nipani. Thank You 23 August 2012 * KLE College of Pharmacy, Nipan