Expedited Oral Solid Dosage Development

In 2021, Americans spent $525 million on oral solid dosage forms, of which tablets made up 53.1% of the market. (1). Tablets are the most popular drug delivery method because of the relatively low cost of ingredients, ease of manufacturing, and high patient compliance (1). In the early stages of formulation development, when drug availability is limited and expensive (2), the current methodology of making  tablet formulations require kilograms of the drug (also known as active pharmaceutical ingredient or API) and months to years to make a successful formulation and test them on industrial scale equipment. This method of large-scale formulation development is done to try and ensure that the formulation will work at the production scale, but by understanding the material’s properties of the API, a successful commercial formulation can be designed using minimal API. In this work, we used material-sparing techniques to measure the relevant material properties of five different APIs. From that analysis, we developed powder formulations that complimented the materials’ properties of each API and improved the likelihood of successful tableting. Analysis of powder formulations for critical processability criteria was done to ensure scalability to industrial production. Using this methodology, we produced a successful tablet formulation for each API using less than 30 grams of API in less than 30 days.

1. Insights, F. M. Oral Solid Dosage Pharmaceutical Formulation Market Outlook (2022-2032); https://www.futuremarketinsights.com/reports/oral-solid-dosage-pharmaceutical-formulation-market, September 2022, 2022; p 152.
2. Yamashita, H.; Sun, C. C.. Material-sparing and Expedited Development of a Tablet Formulation of Carbamazepine Glutaric Acid Cocrystal– a Qbd Approach. Pharmaceutical Research 2020, 37 (8). https://doi.org/10.1007/s11095-020-02855-3.