Alcami contributed to a roundtable featured in Pharmaceutical Outsourcing magazine titled "Oral Solid Dosage Manufacturing Roundtable." The article discusses a variety of topics including current critical issues facing the industry in regards to oral solid dosage manufacturing, new manufacturing technologies/processes, the affect that globalization of the pharma industry has had on oral solid dose manufacturing, and more.
What are some of the current critical issues facing the industry in regards to oral solid dosage manufacturing?
Alcami: A critical obstacle for oral solid dosage manufacturing that can extend into other dosage forms is variations in excipients and active pharmaceutical ingredients (APIs). For oral solid dosage manufacturing, the variations have shown impact in processing parameters such as flow of the material into milling operations and/or final dosage operations (i.e. encapsulation, compression). There are some cases where the variations can impact testing parameters (i.e. disintegration, dissolution). In most cases, time and money is spent to characterize the process and materials by performing design of experiment studies using multiple lots of the material, but the studies are only testing a small sub-lot of these multi-ton processes. Sometimes the excipients are processed in large batch sizes making any variations difficult to detect during initial material testing.
The same impact is found in APIs. In one particular case, it was not a surprise that the dissolution rate of an immediate release tablet was dependent on particle size, however, as part of an investigation, it was determined that the API supplier was completing a sublot milling process that blended different particle sizes to meet another testing parameter. The blending process was introducing random failures within the process. This example highlights the importance of open communication between the excipient and API suppliers.