Quality Assurance of Medicines in Practice

Investigating the physical stability of repackaged medicines stored into commercially available multicompartment compliance aids (MCAs)

“…The stability of a pharmaceutical product can be defined as ‘the capability of a particular medicine, in a specified container, to remain within its physical, chemical, microbiological, therapeutic and toxicological specifications’ . The shelf life of a formulation is greatly affected by the intrinsic stability of the active pharmaceutical ingredient (API), the excipients, the potential interactions between them, the manufacturing process, the packaging and environmental conditions encountered during transport of the product and its storage conditions . Manufacturers’ packaging is specifically designed to protect the medicinal product from environmental factors encountered during storage, such as light, air (oxygen, carbon dioxide and other gases), and moisture, whilst also limiting the interactions between the dosage form and the packaging material .…”

“…The shelf life of a formulation is greatly affected by the intrinsic stability of the active pharmaceutical ingredient (API), the excipients, the potential interactions between them, the manufacturing process, the packaging and environmental conditions encountered during transport of the product and its storage conditions . Manufacturers’ packaging is specifically designed to protect the medicinal product from environmental factors encountered during storage, such as light, air (oxygen, carbon dioxide and other gases), and moisture, whilst also limiting the interactions between the dosage form and the packaging material . API stability within a dosage form is routinely confirmed according to international regulatory requirements, where stability studies on packaged medicines are conducted under long‐term and accelerated conditions at specific temperatures and relative humidity (RH) to represent storage conditions experienced in the distribution chain of the climatic zone(s) of the country or region of the world concerned …”

“…The use of MCAs involves the transfer of medicines from the manufacturer's original packaging into the MCA. The Royal Pharmaceutical Society (in the United Kingdom) advises that ‘medicines should not be stored in a MCA for longer than 8 weeks’ and have noted (along with Glass and Haywood) that there is a lack of sufficient stability data available to support the repackaging of medicines into MCAs. Anecdotal (from both community and hospital pharmacists) and literature evidence (such as from Haywood et al .…”

Quest for good quality medicines in hospitals: a structured approach

“…For many medicines, prevention of contact with air or exposure to light and maintenance of appropriate temperature is important. 8,20 Some examples are:…”

“…8 Lesser the number of drugs to be procured, lesser is the risk of exposure to poor quality medicines. Drug and therapeutics committees (DTCs) duly constituted and contributed by multiple specialities select and approve procurement of a limited number of agents amongst many in a particular drug class, thus deciding the hospital formulary based on standard treatment guidelines (STG).…”