EXTEMPORANEOUS PREPARATIONS OF PEDIATRIC ORAL FORMULATIONS: STABILITY STUDIES CONDUCTED IN SPIRONOLACTONE SUSPENSIONS, POWDERS AND CAPSULES IN SAUDI HOSPITAL PHARMACIES

Ismail M Mahmoud, M and Yassir M Ibrahim, M and Mahmoud A Shakir, A and Amgad A Awad El-Gied, A and Ismail M Mahmoud, M (2014) EXTEMPORANEOUS PREPARATIONS OF PEDIATRIC ORAL FORMULATIONS: STABILITY STUDIES CONDUCTED IN SPIRONOLACTONE SUSPENSIONS, POWDERS AND CAPSULES IN SAUDI HOSPITAL PHARMACIES. Journal of Global Trends in Pharmaceutical Sciences, 5 (2). pp. 1595-1602. ISSN 2230-7346

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Abstract

The lack of appropriate pediatric formulations is a worldwide problem Pharmaceutical companies manufacture special preparations for paediatric patients mainly if the products are likely to be marketable and will generate profit for the manufacturer .The range of doses used may be wide for paediatric patients, because of the developmental changes that occur during a child lifetime. Suitable dosage forms formulated in much different strength by including harmless excipients would be needed to medicate children of different ages. Therefore, extemporaneously prepared products are still required to ensure that accurate doses and suitable dosage forms. The present study aimed to investigate physical and chemical stabilities, content uniformities and microbiological stability of extemporaneously prepared spironolactone oral suspensions to be used in newborns and infants, prepared extemporaneously in Saudi hospitals from spironolactone tablets. The stability of spironolactone in suspensions prepared extemporaneously by four Saudi hospitals at Aseer region and those prepared in the pharmaceutical laboratory were studied. Also Spironolactone oral powders and capsules were prepared by mixing crushed and carefully ground spironolactone tablets and the geometric amounts of either lactose or microcrystalline cellulose to achieve a final spironolactone concentration of 1.0 mg/unit. The resulting powder was divided into portions in powder papers or capsule shells. At intervals up to thirty five days. The suspensions were visually inspected for color and odor change precipitation, sedimentation and rheological properties.Also the suspensions were tested for changes in pH, as well as for microbial growth. The powders and capsules were assayed at interval up to 6months. Samples were assayed for spironolactone content by a reproducible and validated stability-indicating Spectrophotometric method. During the first 14 days of storage, mean spironolactone concentrations in all suspensions were >90% of the initial concentrations. After 30 days only one suspension remained stable, with >90% of the initial spironolactone concentration. Suspensions pH remained unchanged throughout the period of test and there were no changes in physical appearance. Also counts of bacteria and fungi remained within acceptable limits within 35 days. Only one spironolactone suspensions (1 mg/ml) was found to fulfill the expiry date (one month) stated in the labels. The content uniformities of spironolactone powders and capsules complied with the test specifications. The content of spironolactone theoretical content 1.0 mg was 0.92 ± 0.03 mg in powders. Oral powders and capsules filled with the powder of crushed tables were stable for up to 6months and were faster to prepare and upon comparing the quality, do represent an alternative to oral liquids.

Item Type: Article
Subjects: Pharmaceutical Sciences
Pharmacy
Divisions: College of Pharmacy > Pharmacy
Depositing User: Amged Algied
Date Deposited: 24 Apr 2017 08:30
Last Modified: 24 Apr 2017 08:30
URI: http://eprints.kku.edu.sa/id/eprint/590

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