Drug Preformulation

Some of these drug preformulation studies can also provide data on the expected performance of a drug during in vivo, or human, trials.

Excellent preformulation testing will come only after careful consultation with a client regarding their exact needs. The best companies can carefully tailor the results of the testing to include only those readings and results that will be important to the specific dosage being used in a formulation. These drug preformulation analyses can include a variety of tests and pinpoint studies. One of the examinations that can be done is an x-ray diffraction of small molecules to examine the smallest elements of ingredient substances. Additionally, tests can examine the stability of the ingredients, accelerating the decomposition process to examine long-term stability of the ingredients and evaluate the pH at various temperatures. The analysis will at least evaluate the active pharmaceutical ingredient in accordance with official guidelines such as USP-NF, EP and BP.

Another service that drug preformulation testing can provide includes lot to lot analyses, looking at the consistency of the ingredients between different lots of the pharmaceutical. Also, a bulk and tap density evaluation can offer more insight into the efficacy of a proposed formulation.

Other services to look for include particle sizing and identification of and the measurement of any impurities. The analysis will also include partition coefficient and distribution as related to the pH of a substance, and will also look at how easily the substance breaks down when exposed to light.

There are also tests for pH solubility of components in the pharmaceuticals, and a pka determination test. A thermal analysis can give information about how the components of a compound react at different temperatures, and toxicology formulations look at all the different ways a product might be delivered to the consumer, such as through a solution or suspension, or through a gel or cream. Delivery in a capsule is another possibility that would be tested in a good screening.

An independent formulation development company can give the most reliable and valuable analyses for preformulation testing. These companies will also carry the most weight during the testing and approval processes. With the help of an excellent laboratory providing such testing, a pharmaceutical company has a partner in developing the best compounds, analysis, and manufacturing, giving the best chance for a desired outcome in the final testing process.

An important factor to consider when choosing a company is their efficiency and timeliness in returning results. Making a good company choice for drug preformulation testing can provide a faster approval process and important information for a company's formulation needs.

Derek Hennecke is a founding member of Xcelience, which specializes in pharmaceutical manufacturing. Prior to this, Derek was Vice President and General Manager, Pharmaceutics and Biopharmaceuticals of MDS Pharma Sciences, Inc. In this capacity, he was responsible for the business and operations of MDS's CRO formulation development.