The Essence of Drug Formulation

1. The Essence of Drug Formulation Facing delays with ongoing Pharmaceutical development programs? Too much unnecessary expenditure with clinical trials? If yes then, here’s another question. Are you sure your drug formulation is correct? The science of drug formulation is relevant from the pre-clinical stage, from day one. Apart from identifying the API (active pharmaceutical ingredient) for given ailment, it is important to determine the ‘form’ or formulation with which it can have the desired effect. Traditionally, Formulation Development is all about boosting the bioavailability of the drug within the patient’s body. But today, his/her convenience and safety is also of great concern. Additionally, the formulation development ensures that the inert chemical substances encasing the drug are compatible to the latter, so that the combination does not have any adverse effects on the body. Also, there are various formulation types based on their route of administration or the application location. For instance, tablets and capsules are administered via the oral route. There are four important factors that influence formulation development, and the bioavailability or effect of the drug in the patient’s system. 1.Particle Size/Design 2.Polymorphism 3.pH (acidity/basicity) 4.Solubility 5.According to Research Gate publications, the particle size of the drug substance is important when it comes to fully realising the physicochemical and biopharmaceutical potential of the same. There are multiple methods to achieve the right particle diameter, which again depends on the dispersion mechanism. To finalise on one, the lab must cross-correlate between the different techniques. Earlier, particle design was limited to their use as carriers across the body. But with developments in therapeutic approaches and advanced dosage forms,

2. particles are engineered to meet specific requirements in the active stabilization of the drug & its circulation. 6.Polymorphism is the ability of pharmaceutical solids to exist in more than one form, to have the desired effect in different bodies and environmental conditions. Like particle size, one must also identify the right polymorphic form based on the medicinal value of the drug, and the required flow within the system. Polymorphism also influences efficacy and toxicity of the drug, in addition to other bioavailability factors. 7.As for pH levels, they largely control the solubility, stability and permeability of the drug. The solubility of acids and bases in the drug keeps increasing and decreasing with pH levels. They also directly determine the degradation rate of the drug and its penetration through membranes. 8.Last but not least, solubility is an outcome of all of the above. The bioavailability of the drug largely depends on its solubility in aqueous gastrointestinal fluids present in the body, and its permeability through cell/biologic membranes. 9.Currently, technological advancements are giving formulation development programs cutting edge tools and processes, in order to achieve precision and expedite the time-to-market. Moreover, an integrated approach towards the specific needs of a phase, with a thorough understanding of the API's properties, can greatly minimize risk, reduce costs and save on time. 10.At Kemwell, our supply chain is like a well-oiled machine. If you need a partner going into the pharmaceutical business, get in touch with us. To Know More Visit: http://www.kemwellbiopharma.com/