After operating under the Ferro umbrella for 13 years, Ferro Pfanstiehl Laboratories was purchased by PLI Holdings, an affiliate of Med Opportunity Partners (MEDOP). James Breckenridge, founding member of MEDOP, and Cynthis Kerker, president of Pfanstiehl, discuss why the acquisition is good news for the future growth of Pfanstiehl, and how the company's products, focus on quality, and SafeBridge certification made them a good fit with MEDOPs other strategic partners.
Formulation in bioresearch is directly associated with pharmaceutical research and development. It is the practice of combining different chemical substances that include the active medical drug. This combination of drug and chemicals is tweaked until they have a final medicinal formulation that can be tested and receive final approval for large-scale market use.
The object of pre-formulation and formulation is to develop a stable preparation of a specific drug that is acceptable for human consumption. All drugs, by necessity, contain other chemicals. In order to put a drug into a capsule or tablet form it requires a variety of substances other than the drug itself. Formulation is needed to ensure that the drug will work when combined with these other substances.
It may surprise you to know that most formulations are not complete until after Phase III clinical trials are in progress or completed. All the early trials test drug stability, and drug load, which is the ratio of active drug to the total content of the actual dose.
Formulation studies address a variety of issues includinggrain size, pH (acidic or alkaline), solubility, and polymorphism (the ability of a drug to exist in more than one form like liquid and capsule). Other items formulation addresses is taste, appearance, tablet hardness and tablet or capsule disintegration.
Another aspect of formulation is testing how humidity, temperature, oxidation, ultraviolet light or visible light affects the formulation. The formula must be stable and not degrade under all of the different environmental factors.
Formulation involves a lot of experimenting with different blends of materials and drugs, but is absolutely crucial for the development of effective, safe, stable, oral drugs, and topical ointments.