Gelken Clarifies Pharmaceutical Gelatin Standards and Applications

Gelken, a manufacturer of pharmaceutical gelatin, has published an informational guide addressing the various grades, pharmacopeial standards, and applications of pharmaceutical gelatin. The company seeks to provide clarity for manufacturers and buyers regarding the material's complex specifications, which are critical for drug and supplement production.

The publication explains pharmaceutical gelatin as a high-purity protein produced under Good Manufacturing Practices (GMP) and tested against pharmacopeial monographs. It serves as an excipient, functioning as a carrier for active pharmaceutical ingredients (APIs) in capsules, a binder or coating agent in tablets, and for microencapsulation. The selection of the appropriate gelatin grade—gelling or non-gelling, Type A or B, and specific Bloom strength—directly impacts the final product's dissolution, stability, and regulatory compliance.

Gelken highlights the quality standards set by four major pharmacopeias: the United States Pharmacopeia (USP), European Pharmacopoeia (EP), British Pharmacopoeia (BP), and Japanese Pharmacopoeia (JP). These standards define critical parameters such as gel strength (Bloom), pH, heavy metal content, and microbiological limits. The guide notes that the harmonisation of gelatin monographs across USP, EP, and JP, completed in 2019, simplifies requirements for global suppliers.

The article further distinguishes between gelling and non-gelling gelatin grades. Gelling grade gelatin is used for capsule shells and microencapsulation, while non-gelling grade serves as a binder for tablets and in coating applications. Gelken offers both types, tailored for specific uses such as the production of hard and soft pharmaceutical capsules, and as excipients for tablet formulation.