(282) A Simplified Approach for Compounding Slow Release Capsules in Pharmacy Practice

Objective : Physicians often prescribe slow-release capsules to increase patient adherence and improve pharmacotherapy. However, due to changes in excipient(s) or their ratio, the release kinetics of these SR formulations might vary thus posing a significant risk of toxicity. In the current 503A pharmacy setting (traditional compounding pharmacy), researching to develop SR formulations is impractical. In this context, pharmacists can play a significant role by preparing and testing different strengths of drug excipient blends for SR preparations by using a simple Alligation Method in a 503B compounding pharmacy (an outsourcing facility) and distributing to 503A pharmacies to compound SR capsules/tablets.

Methods: To address this novel approach, SR capsules of thiamine hydrochloride were prepared by both dry and wet mixing processes using 40% HPMC and different lactose proportions. The release kinetics of these formulas were tested using the developed HPLC method, where solvent A contained 60% water, methanol, and glacial acetic acid (73:27:1), and in solvent B, 40% methanol was used.

Results: Results showed that 100% of the drug was released by 8 hours from the SR capsules for both dry and wet formulations, and the percentage of drug release from the 75 mg and 100 mg capsules prepared by the wet processes were significantly higher and more consistent than the dry mix method throughout the dissolution period.

Conclusions: We suggest providing different premix blends distributed by a 503B outsourcing facility per the US FDA regulations to 503A pharmacies to compound SR capsules. This approach will ensure appropriate prescriber dosing, adequate release profiles, and quality for sufficient efficacy and patient safety.