There are few common challenges are faced by pharmaceutical company during product development. Where includes -

  • Feasibility study
  • Formulation development
  • Analytical method development
  • Technology Transfer
  • Manufacturing process development
  • Product lifecycle management

From  these aspect the aim of this article to briefly discuss about the development of a generic tablet core formulation to have similar dissolution profile to that of the reference product, since the dissolution profile of the film-coated tablet would not be greatly affected by the coating.

At first preformulation study is to be conducted to characterize the API and RLD. Then depending on the API nature manufacturing process is selected whether dry granulation or wet granulation or direct compression. Formulations by direct compression are highly dependent on the properties of the raw materials including the drug substance and drug-excipients ratio.

Before excipients selection drug-excipients compatibility study to be performed by forced degradtion or stress study. The amount of excipients and grade of excipients also to be optimized during the development stage. Where include paricle size, loss on drying, water content, bulk density, tapped density, microbial analysis report etc.

During compression of core tablets following variables should be optimized - 

1. Compression Force

2. Ejection at compression forces

3. Take-off at compression forces

4. Hardness at compression forces

5. Disintegration at compression forces

6. Percentage of friability at compression forces

7. Weight variation at compression forces

8. Thickness (inch) at compression forces

9. Dissolution rates of various formulations

After satisfactory physical and chemical results found, critical process parametrs and variables should note down to define CPP and CQA during large scale production.

Choice of a dissolution medium is an important and critical variant for drug dissolution testing. The reported choices range from a simple solvent (water) to complex solutions, often drug and/or product dependent. However, making a choice is not so simple or straightforward, but confusing and often scientifically or logically not convincing or valid. This article provides a discussion in this regard leading to suggestions for selecting an appropriate dissolution medium.

After development at R&D facilities, the main challenges are begin with analytical method and manufacturing process transferring activities. Where trained personnel or sender unit personnel to be present with receiver unit personnel.

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