A better understanding on gelatin cross-linking: causes, control strategy and regulatory approaches

Gelatin is a water-soluble protein material that is extensively used in several applications, including food, pharmaceutical and photography, among others. In the pharmaceutical field it is mainly used for manufacturing of hard and soft capsules, gelatin coated tablets and in some cases as a binder for tablets. Gelatin possesses many advantages compared to other natural polymers, such as not toxic and to be dissolved at the corporal temperature in the biologic fluids.Gelatin can be obtained from several sources including bones, skin and ligaments from animals like pigs, fish or cows; and using different types of processes including chemical (either basic or acid) hydrolysis and enzymatic methods. All those potential combinations affect the final composition and chemical properties of the obtained material and could therefore affect its performance, including dissolution properties which can affect the stability of drug products where gelatin is used for different purposes.This live webinar will give you an overview on gelatin properties. We will discuss the tests included in USP and other compendia but also other characteristics of gelatin that are not normally taken into account but that can affect physicochemical properties of gelatin related to dissolution or stickiness. Emphasis will be given to the different Critical Quality Attributes (CQAs) that should be evaluated as part of the QbD (Quality by Design) strategy during the development of drug products containing gelatin. Additionally, we will discuss regulatory and potential in-vivo implications of cross-linking failures on the drug product stability and different approaches that can be followed based on USP and ICH recommendations.Company summary:Softigel is Procaps' strategic business unit for contract manufacturing and product development services, supporting healthcare and related businesses by developing, manufacturing and commercializing pharmaceutical products, nutritional supplements, veterinary formulations and cosmetics in soft gelatin capsules and advanced delivery technologies.Since establishing soft gelatin capsule production in the city of Barranquilla, Colombia in 1977, Procaps is now Latin America's largest softgel producer with facilities in Brazil, Colombia and Venezuela, and exports reaching more than 42 countries worldwide. Specialized in softgel technologies, Procaps offers access to other delivery systems such as nutritional gummies, tablets and powders, hard gelatine capsules, creams, ointments and gels.As the leading manufacturer of soft gelatin capsules in Latin America, Procaps caters to multinational pharmaceutical clients, including Pfizer, GlaxoSmithKline, Sanofi-Aventis, Boehringer Ingelheim, and Bayer among others. Its facilities are fully in accordance with current Good Manufacturing Practices (cGMP), certified by all regulatory authorities in Latin and North America, and is the first Latin American manufacturer of pharmaceutical soft gelatin capsules approved by the US FDA.