USP June Workshop to Focus on Dissolution Challenges

Dissolution testing of how a product dissolves and releases active ingredients in the body is key to determining a product’s performance and efficacy. For instance, dissolution testing of tablets and capsules is done as an in vitro indicator of how an active component releases from its formulation consistently over time. On June 11 to 12, the U.S. Pharmacopeial Convention (USP) will host a workshop titled “Challenges in Dissolution” at its headquarters in Rockville, MD. The workshop will discuss and promote understanding of issues stemming from the dissolution testing of different dietary supplement and drug dosage forms.

USP’s Dietary Supplements Compendium includes dissolution standards for dietary supplements and their ingredients. The group says that as newer dosage forms enter the market, it’s become more necessary than ever to ensure dissolution quality.

“Since many pharmaceutical products have been developed as immediate-release solid oral dosage forms…dissolution testing standards for these products have been well-defined for some time,” said USP in a press release. “However, procedures for testing newer formulations, including semisolid dosage forms like creams, ointments, gels, and lotions, some of which are considered to be extended-release preparations, are less well-defined and accepted.” For dietary supplements, USP says that the development of USP dissolution standards related to nutrients such as fat-soluble vitamins and botanical materials will be discussed.

Issues related to liquid-filled and gelatin capsules will also be discussed. “The growing popularity of soft gelatin capsules-especially for dietary supplements-has made understanding the role of enzymes in dissolution a critical consideration for manufacturers,” said USP. “Enzymes like pepsin are used to break up the cross-linked gelatin in capsules and can perform additional functions associated with fill material used in this type of formulation, paralleling the roles they perform in the body. During dissolution testing, manufacturers must confirm that the dissolution media used do not adversely interact with the enzymes and that enzymatic activity is preserved. A workshop session will be dedicated to the role of enzymes in dissolution testing.”

“Forums such as USP’s workshop on dissolution testing help to ensure that important quality issues related to a growing number of product formulations are brought to the forefront, and that public standards are developed to support them,” stated Praveen Tyle, PhD, USP’s chief science officer and executive vice president.