What Is the Significance of Topical Formulation Development

topical formulation development

 

Even after the exemption of novel excipients, many components are available that one can use in topical formulation development. Selecting the right ones is extremely important. A single wrong excipient can change the drug's ability to penetrate the skin, stability of the drug, its shelf life, or the capability to yield the desired rates. What is the purpose of such a drug? Let us understand the significance of the correct excipients by a few examples.

  • One of the topical drugs of Tergus is utilized as an emulsion cream so that the drug dissolves up to a specific concentration. So they select the excipients that will increase the solubility of the drug. Also, the manufacturer has to take care to prevent oil and water phase separation. Despite all this, a change in formulation resulted in phase separation. The team again made the drug to optimize the concentration of emulsifiers by adding viscosity-generating excipient. 
  • In another project of Tergus, the pre-formulation solubility of a novel molecule was affected. Deep analysis was done, which showed drug substance degradation and increasing impurity levels. Further studies were done to find out the exact excipients causing degradation so that substitutes could be found. 
  • Take one more drug project of Tergus as an example. During the development process, it is noticed in the process of skin permeation, efficacy was best when an amalgamation of two permeation enhancers was combined. The early analysis will help incorrect selection of excipients. At whichever stage you find something wrong, the process must get redone. Analysis of the unsuitable excipients helps to prevent the same mistakes in future formulations.

 

Like all development processes, topical formulation development requires both research and experiment. Sometimes experiments in the formulations lead to better drug production, as we saw in the example above. Pay attention to the permeation enhancers during the early stages. To choose the perfect excipient, consider the bioavailability of the drug at the location, called the epidermis.

Location: Bengaluru, Karnataka, India

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