Stability Studies of Extemporaneous Pharmaceutical Products

Abstract

Extemporaneous pharmaceutical preparations are the products that are compounded for an individual patient for a specific condition. Such preparations are usually compounded and dispensed due to lack of suitable dosage form, medicine dilution for pediatrics and geriatrics, lack of commercially available topical preparation, or absence of license medicine for certain diseases. Therefore, the extemporaneous pharmaceutical products must abide by the standards of compounding to ensure the safety and efficacy of the drug. The extemporaneous preparations fall under two broad categories of simple and complex ones. Simple extemporaneous preparations are the preparations that do not require any specialized facilities such as topic creams, ointments, tablets, and suppositories, whereas the complex extemporaneous parenteral and ophthalmic preparations require specialized equipment and training. The oral liquid dosage forms are most commonly prepared extemporaneously among all these preparations. The stability of extemporaneous preparations is highly critical; hence the formula utilized for extemporaneous dispensing should be preferably validated and have sufficient stability evidence. Each extemporaneously prepared dosage form possesses distinct stability testing and must be evaluated against these parameters. In general, good laboratory practices must be satisfied while compounding extemporaneous preparation. The stability studies of extemporaneous preparations along with suitable examples are briefly discussed under this chapter.