Extemporaneous Compounding

Basic concept of extemporaneous preparation.

1. Extemporaneous Compounding Prepared By: Nishant Shrestha M. Pharmacy (Clinical)

2. Extemporaneous compounding Extemporaneous compounding is defined as the timely preparation of a drug product according to a physicians prescription, a drug formula, or a recipe in which calculated amounts of ingredients are made into a homogenous (uniform) mixture. Example: Captopril syrup Captopril powder  Extemporaneous compounding is done when certain medical needs of individual patients cannot be met by the use of an approved commercial drug product.

3. Reason and Purpose for Extemporaneous Compounding Unavailable dosages, strengths and routes of commercial products Dilution of adult doses of medications to Pediatric/Geriatric strengths. Conversion of solid dosage forms to solutions or suspensions. Combination of topical dermatological products not available by the manufacturer. Inactive ingredients of commercial products which may cause allergic reactions in individuals.

4. Advantages of Extemporaneous Compounding

5. Problems Encountered in Extemporaneous Compounding

6. General Principles of Labelling

7. General Principles of Labelling

8. General Principles of Labelling

9. Quality Assurance and Safety of Extemporaneous Preparation Pharmacist (or trained personnel) should prepare and dispense compounded products in a manner that ensures product quality, safety and efficacy and in accordance with good compounding practices, official standards and relevant scientific data and information (if such information exists). Appropriate stability evaluation is performed or determined from the literature to establish reliable expiry data to ensure that the finished preparations have their expected potency, purity, quality and characteristics, at least until the labelled expiry date. There should be assurance that processes are always carried out as intended or specified and are under control. The relevant master document should be selected and a product specific worksheet and label should be prepared before starting preparation. Where a calculation is required, it should be independently checked by an appropriate second person wherever possible. The check should be performed prior to preparation to minimize the chance of product wastage.

10. Use of suitable containers and correct labelling Primary packaging of the product must be fit for purpose and adequately protect the product from the environment whilst being compatible with the product. Ideally the product must be labelled with the necessary particulars, including any special requirements for the safe handling or storage of the product:  common name of product statement of the active ingredients expressed qualitatively and quantitatively per dosage unit or for a given volume or weight   dose and route of administration contents of the container by weight, volume or number of doses expiry date batch number name and address of patient

11. EXAMPLE: Amiodarone hydrochloride oral liquid (Extemporaneous Preparation) Using a typical strength of 40 mg/mL A miodarone hydrochloride 200 mg tablets * 20 Ora-Plus 50mL Ora-Sweet SF to 100 mL. Method guidance Tablets can be ground to a fine, uniformpowder in a pestle and mortar. A small amount of Ora-Plus may be added to form a paste, before adding further portions of Ora-Plus up to 50% of the final volume. Transfer to a measuring cylinder. The Ora-Sweet can be used to wash out the pestle and mortar before making the suspension up to 100% volume. Transfer to an amber medicine bottle. Shelf-life 28 days refrigerated or at room temperature in amber glass. Shake the bottle.