The monograph – which was published in September in the Pharmacopeial Forum (42-4) – defines the non-animal product derived capsules as consisting of two pieces, a body and a cap, which overlap and maintain a tight closure.
The document also specifies the materials from which hypromellose capsules can be made and how they can be combined with plasticizers, surfactants, gelling agents, dispersing agents, flavoring agents, antimicrobial agents, and sweeteners.
The monograph also specifies the drying, disintegration and microbial resistance tests the capsules must pass and outlines appropriate storage conditions.
The United States Pharmacopoeial Convention (USP) called for industry feedback, extending the original September 30 deadline for comments.
Some suppliers have already commented.
A Capsugel spokesman told us “Capsugel is pleased that USP is developing a monograph for HPMC capsules as it helps to provide clarity to the industry. As such, we were happy to provide detailed technical input to USP when requested.”