Medicinal products including drugs (capsules, pills, tablets and supplements), semi-solid drugs (suspensions and syrups), sterile liquids (nasal, ophthalmic and oral), topical applications (creams, ointments, gels, pastes and powders) and injectables (subcutaneous, intramuscular and intravenous) are subjected to stringent manufacturing processes and trials before they are finally availed into the market for treatment and management of diseases and other health conditions. One of the most important processes is formulation development, a pharmaceutical formulation process undertaken by pharmaceutical scientists. It involves studying and determining how different chemical substances need to be combined with an active medicinal element to produce a specific medicinal product that is eventually released into the market.
It is through formulation that pharmaceutical scientists determine a medicinal product’s particle size, solubility, PH and polymorphism. All these factors have an effect on a medicinal product’s bio-availability, which informs its activity level once in the body. Development of medicinal product formulation usually starts with pre - formulation, a process that involves determining the characteristics of a medicinal product to be manufactured. It is in this process that pharmaceutical scientists determine the physical, mechanical and chemical properties that an intended medicinal product must conform to. Determining these factors informs on the type of ingredients to be used in addition to the active medicinal ingredient. In most cases, medicinal products only contain between 5% and 10% of active ingredient. About 90% of any medication is largely made up of lubricants, binders, coating, integrands and fillers.
Although medicinal products are usually made available for clinical trials soon after they are manufactured, formulation studies are usually not complete by then. Medications used in clinical trials are therefore simple formulations. Those used in the last phase of clinical trials (usually phase III) are usually made available after formulation studies are over. This means that the medications are released into the market once a clinical trial has proved successful and approved. Pharmaceutical manufacturers are however obligated to show proof that their final medicinal products conform to scientifically set temperature, oxidation and humidity limits.
Pharmaceutical manufacturers do not only undertake the development of medicinal development; they provide other very critical services to their clients. In any case, medicinal products already released are continuously improved, which literally means that formulation studies for the purpose of improving such medications are usually on course. Other services that the manufacturers provide include formulation of new chemical elements that are used as ingredients and development of dosage forms amongst other services.