Technology Transfer in Excipients according to WHO Guidelines Industrial Pharmacy

Transfer of Technology for Excipients according to WHO Guidelines

The excipients to be used have a potential impact on the final product. Their specifications and relevant functional characteristics should, therefore, be made available by the SU for transfer to the RU site. 

The following are examples of the information which may typically be provided; however, the information needed in each specific case should be assessed using the principles of QRM:

• manufacturer and associated supply chain;
• description of functionality, with justification for inclusion of any antioxidant, preservative or any excipient;
• definitive form (particularly for solid and inhaled dosage forms);
• solubility profile (particularly for inhaled and transdermal dosage forms);
• partition coefficient, including the method of determination (for transdermal dosage forms);
• intrinsic dissolution rate, including the method of determination (for transdermal dosage forms);
• particle size and distribution, including the method of determination (for solid, inhaled and transdermal dosage forms);
• bulk physical properties, including data on bulk and tap density, surface area and porosity as appropriate (for solid and inhaled dosage forms);
• compaction properties (for solid dosage forms);
• melting point range (for semi-solid or topical dosage forms);
• pH range (for parenteral, semi-solid or topical, liquid and transdermal dosage forms);
• ionic strength (for parenteral dosage forms);
• specific density or gravity (for parenteral, semi-solid or topical, liquid and transdermal dosage forms);
• viscosity and or viscoelasticity (for parenteral, semi-solid or topical, liquid and transdermal dosage forms);
• osmolarity (for parenteral dosage forms);
• water content and determination of hygroscopicity, including water activity data and special handling requirements (for solid and inhaled dosage forms);
• moisture content range (for parenteral, semisolid or topical, liquid and transdermal dosage forms);
• microbiological considerations (including sterility, bacterial endotoxins and bioburden levels where the excipient supports microbiological growth) in accordance with national, regional or international pharmacopoeial requirements, as applicable (for general and specific monographs);
• specifications and justification for release and end-of-life limits;
• information on adhesives supporting compliance with peel, sheer and adhesion design criteria (for transdermal dosage forms);
• special considerations with implications for storage and or handling, including but not limited to safety and environmental factors (e.g. as specified in material safety data sheets (MSDS)) and sensitivity to heat, light or moisture; and
• regulatory considerations, e.g. documentation to support compliance with transmissible animal spongiform encephalopathy certification requirements (where applicable).