25 Sep2014
ORA-RANGE FAQs
Besides Secundum Artem, what other compounding resources are available?
There are a number of texts and a journal you may be interested in purchasing. This includes; Trissel’s Stability of Compounded Formulations, 4th Edition published in 2009 by the American Pharmacists Association. Pediatric Drug Formulations, 5th Edition published in 2003 by Harvey Whitney Books Company. Extemporaneous Formulations, published in 2003 by the American Society of Health-System Pharmacists. The Art, Science and Technology of Pharmaceutical Compounding, 3rd Edition published by the American Pharmacists Association in 2008. International Journal of Pharmaceutical Compounding, available by subscription at the link below. http://www.ijpc.com/
What is Secundum Artem?
Secundum Artem is a collection of articles on various topics of pharmaceutical compounding. Articles are published twice each year. Complimentary continuing education, supported by Paddock Laboratories, is provided for the most recent issues.
Can Tamiflu capsules be compounded into an extemporaneous oral liquid if the commercial Tamiflu powder for oral suspension is unavailable? Is stability information available?
Yes. A stability study of a compounded Tamiflu 15 mg/mL oral liquid in a vehicle of Ora-Sweet SF was published in the November/December 2007 issue of the Journal of the American Pharmacists Association. Winiarski et al found the preparation to be stable for up to 35 days at either 5°C or 25°C and up to 13 days at 30°C. This information is now included in part under the Dosage, Administration and Storage section in the Tamiflu Package Insert.
What are Stability Studies?
Stability is defined as the capacity of a drug substance or drug product to remain within the established specifications to maintain its identity, strength, quality and purity through out the retest or expiration dating period. The objective of stability study is to determine the shelf life, namely the time period of storage at a specified condition within which the drug product still meets its established specifications. acheter viagra Stability is an essential factor of quality, safety and efficacy of a drug product. A drug product, which is not of sufficient stability, can result in changes in physical (like hardness, dissolution rate, phase separation etc.) as well as chemical characteristics (formation of high risk decomposition substances). The chemical stability of drug is of great importance since it becomes less effective as it undergoes degradation. Also drug decomposition may yield toxic by products that are harmful to the patient. Microbiological instability of a sterile drug product could also be hazardous.