Extemporaneous drug preparations, which are compounded by a pharmacist at a clinical site, are commonly used in early clinical studies to evaluate the performance of drug candidates. However, the types of formulations compounded have been limited to relatively simple preparations such as solutions, suspensions and active ingredients filled into capsules. This article describes the preparation of advanced formulations, specifically extemporaneously prepared matrix tablets and osmotic capsules, which can be used to evaluate the feasibility of controlled release for exploratory new drug candidates or new formulations of existing drugs with a differentiated medical advantage. Extemporaneously prepared dosage forms enable the rapid assessment (i.e. reduced cycle time) of new formulation ideas with minimal quantity of the active pharmaceutical ingredient needed to demonstrate proof-of-concept.
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Assessment of patients' perception and satisfaction with extemporaneous compounding service in ALERT hospital, Ethiopia.
BMC Health Serv Res
January 2025
Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, Addis Ababa University, P.O. Box 1176, Addis Ababa, Ethiopia.
Background: Extemporaneous compounding for dermatological use is an important therapeutic alternative for patients whose clinical needs are not met by approved drug products circulated in the market. Evaluating patients' perceptions and levels of satisfaction towards such services is an important factor for the adherence of patients and maintaining the quality of healthcare services. The current study aimed to assess patients' perception and level of satisfaction with the compounding service and extemporaneous preparations rendered at ALERT hospital.
View Article and Find Full Text PDFPhysicochemical and Microbiological Stability of Ursodiol Oral Compounded Suspensions.
J Pediatr Pharmacol Ther
December 2024
Research and Development (KI, MC), PCCA, Houston, TX.
Objective: In the United States, ursodiol is commercially available as solid dosage forms, which represents a problem for children who cannot swallow capsules or tablets. There is a lack of an age-appropriate formulation for ursodiol, and the extemporaneous preparation of an oral suspension with an extended beyond-use-date (BUD) may represent a good therapeutic alternative for the pediatric population. However, all pharmacists need validated stability studies to prepare oral liquids with high quality and safety.
View Article and Find Full Text PDFExtemporaneous Compounding of Medicated Ointments.
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December 2024
Midwestern University Chicago College of Pharmacy, Downers Grove, Illinois.
Article Synopsis
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Pediatric Orally Disintegrating Tablets (ODTs) with Enhanced Palatability Based on Propranolol HCl Coground with Hydroxypropyl-β-Cyclodextrin.
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Department of Food, Environmental and Nutritional Sciences (DeFENS), University of Milan, 20133 Milan, Italy.
Background: Propranolol, largely prescribed as an antihypertensive and antiarrhythmic drug in pediatrics, is characterized by a bitter taste and an astringent aftertaste. Currently, the therapy requires crushing of tablets for adults and their dispersion in water many times a day, leading to loss of dosing accuracy, low palatability, and poor compliance for both patients and caregivers.
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