Extemporaneous preparation

Several guidelines are available in the literature for the pharmacist who must extemporaneously prepare an ophthalmic solution. The USP contains a section on ophthalmic solutions, as do other compendia and several standard textbooks. Since the pharmacist does not have the facilities to test the product, he or she should dispense only small quantities, with an expiration date of no more than 30 days. Refrigeration of the product should also be required as a precautionary measure. To reduce the largest potential source of microbial contamination, only sterile purified water should be used in compounding ophthalmic solutions. Sterile water for injection, USP, from unopened IV bottles or vials is the highest-quality water available to the pharmacist. Prepackaged sterile water with bacteriostatic agents should not be used. 

Extemporaneous production of pediatric dosage forms is commonly undertaken in hospitals. Without the sophisticated formulation capabilities of pharmaceutical manufacturers, alcohol-based vehicles have been recommended for extemporaneous preparation of liquid dosage forms [73]. There is a critical need to conduct research studies to assist the pharmacist in replacing current formulations with stable, alcohol-free preparations [74]. 

Quercia RA, Fan Cr Liu X, etaf. Stability of omeprazole in an extemporaneously prepared oral liquid Am J Health SystPharm 1997 54 1833-1836 and Dunn A, White M, Reddy P, et al Delivery of omeprazole and lansoprazole granules through a nasogastric tube in vitro. Am J Health Syst Pharm 1999 56 2327-2330. 

Amongst the various types of semisolid preparations, ointments represent the type of extemporaneous preparations most likely to be prepared by a pharmacist. A variety of ingredients may be included in the formula of semisolid dosage forms. 

Aubry, A.F., Sebastian, D., Hobson, T., Xu, J.Q., Rabel, S., Xie, M., and Gray, V., In-use testing of extemporaneously prepared suspension of second generation non-nucleoside reversed transcriptase inhibitors in support of Phase I clinical studies, /. Pharm. Biomed. Anal., 23,535,2000. 

Extemporaneous preparations, such as creams that are prepared in the pharmacy, have an expiry date of 4 weeks. The creams can be stored at room temperature. 

Quercia et al. [171] studied the stability of omeprazole 2 mg/ml in an extemporaneously prepared oral liquid. The contents of five 20-mg omeprazole capsules were mixed with 50 ml of 8.4% sodium bicarbonate solution in a Luer-Lok syringe. Three vials of this liquid were prepared for storage at 24,5, and — 20 °C. A 3-ml sample of each was taken initially and on days 1, 2, 3, 4, 6, 8, 10, 12, 14, 18, 22, 26, and 30 and assayed by HPLC. The liquids stored at 5 and — 20 °C did not change color during the study period, but the color of the liquid stored at 24 °C changed from white to brown. 

Stability Aspects of Radiopharmaceuticals 1.3.6 Extemporaneous Preparation of Radiopharmaceuticals... 

An extemporaneous preparation is defined as a product which is dispensed immediately after preparation and not kept in stock [10]. Hence, many radiopharmaceuticals could fall into this category due to their limited shelf life. 

The use of extemporaneous preparation should be limited to situations where there is no product with marketing authorization (MA) available. This could be prepared based upon a prescription for a named patient (magistral preparation) or a production based upon a formula and prepared on a regular basis. The latter is a... 

Figure 3-8 Ophthalmic sprays can be extemporaneously prepared for defivery of suitable mydriatics or cycloplegics. (Available from Lee Pharmacy, Inc., Fort Smith,Arkansas.)...

An ICH photostability study was performed to investigate the rate and extent of photodegradation that may be anticipated for extemporaneous preparations of phenyl ether drug A formulations that contain TiO. The effect of incremental light exposure levels was examined for both visible and UV light by titrating the amount... 

Remington, J.P. The Practice of Pharmacy A Treatise on the Modes of Making and Dispensing Officinal, Unofficinal, and Extemporaneous Preparations, with Descriptions of Their Properties, Uses, and Doses. Intended as as Handbook for Pharmacists and Physicians and a Text-book for Students et seq J. B. Lippincott Company Philadelphia, 1887. 

Emulsifying agents are used both to promote emulsification at the time of manufacture and to control stability during a shelf life that can very from days for extemporaneously prepared emulsions to months or years for commercial preparations. In practice, combinations of emulsifiers rather than single agents are used. The emulsifier also influences the in vivo fate of lipid parenteral emulsions by its influence on the surface properties of the droplets and on the droplet size distributions. For convenience, most pharmacy texts classify emulsifiers into three groups i) surface active agents ii) natural (macromolecular) polymers and hi) finely divided solids. 

Allen LV. Compounding suppositories Part I Theoretical considerations. Int J Pharm Compound 2000 4(4) 289-293 324-325. Allen LV. Compounding suppositories Part II Extemporaneous preparation. Int J Pharm Compound 2000 4(5) 372-373, 404-405. 

Extemporaneous preparation of suspensions of drugs available commercially only in other dose forms is widely practised in hospital pharmacy, particularly for paediatric use. Dmgs such as acetazolamide, amiodarone and mercaptopurine are examples. In such formulations, alternatives to traditional suspending agents such as tragacanth should be examined. The ideal suspending agent should ... 

The Registration Department evaluates medicines for registration and transparency purposes. It would also make approval decisions on extemporaneous preparations and plant-based and homeopathic medicines. 

The Pharmacopoeia Department works in collaboration with the European Pharmacopoeia, and draw up monographs for raw materials used in extemporaneous preparations. 

The Control Department is responsible for the qucility of finished medicines marketed in Belgium, and of raw materials used in extemporaneous preparations... 

Pharmacy extemporaneously prepared according to Pharmacopoeial standards cind intended for specific patients of that pharmacy. 

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