(410f) On-Demand Drug Product Manufacturing in a Miniaturized System: Can Formulation be Simplified?

Oral direct compressible tablets are the most commonly used drug products. Tablets manufacturing requires design and development of formulations, which need to use several excipients. Choice of excipients depends on the concentration, manufacturability, stability, and bioavailability of the drug substance. Due to a large number of excipients typically used, formulation development becomes complex and tedious. At MIT, we developed a miniature platform for on-demand manufacturing of direct compressible tablets ^{1, 2}. On-demand manufacturing offers a great opportunity to simplify pharmaceutical formulations by minimizing the number of excipients required. In this study, direct compressible tablets of five pharmaceutical drugs, Diazepam, Diphenhydramine HCl, Doxycycline Monohydrate, Ibuprofen, and Ciprofloxacin HCl, with different drug loadings, were demonstrated. This miniature system is able to manufacture on-demand tablets from drug crystals by using the minimum number of excipients required for drug product performance. The critical quality attributes (CQA) of the tablets were assessed to meet the United States Pharmacopeia (USP) quality standards. All drug tablets met USP quality standards after manufacturing and after 2 weeks of accelerated stability test, except for slightly lower drug release for Ibuprofen. We foresee that advancing on-demand ready-to-use pharmaceuticals manufacturing with this type of flexible, miniature, emerging automated (integrated) system will simplify pharmaceutical formulation. This development route will provide significant economic benefits by reducing time-to-market and increasing product quality. In conclusion, this study confirmed that on-demand manufacturing can be used as a promising platform for simplifying the formulations design compared to traditional formulations.

References:

1. Azad M, Osorio Caicedo J, Brancazio D, Hammersmith G, Klee D, Rapp K, Myerson A 2018. A compact, portable, re-configurable, and automated system for on-demand pharmaceutical tablet manufacturing. Int. J. Pharm. 539 (1-2):157-164.
2. Myerson A, Azad M, Hammersmith G, Brancazio D, Osorio Caicedo J. Systems and methods for the fabrication of Ttablets, including pharmaceutical tablets. U.S. Provisional Patent Application US 2018/0271791 A1, Published on September 27, 2018.