ABSTRACT

To facilitate cleaning and sanitization, manufacturing and filling lines should be identified and detailed in drawings and standard operating procedures. Liquid products in which the drug is suspended present some unique manufacturing and control problems. The stability considerations render many drugs unqualified as a liquid dosage form. Liquid formulations often make use of ion resin complexes for immediate release products for drugs that can bind to these resins; the same technology is used to design extended-release products. Microbiological contamination can present significant health hazards in some oral liquids. One area that has presented a number of problems is ensuring the stability of oral liquid products throughout their expiry period. Problems in the packaging of oral liquids have included potency of unit dose products and accurate calibration of measuring devices such as droppers, which are often provided. A liquid fill capsule can be useful when manufacturing small batches if limited quantities of active pharmaceutical ingredient are available.