Formulation Development

Formulation Development

Project 1: Development of a Paediatric Lamivudine, Abacavir and Nevirapine FDC suspension 

This is an executive summary on the assignment that a team of Pharm R&D Lab consultants has undertaken for Medicus Mundi: formulation of a triple combination antiretroviral liquid dosage form for paediatric patients to be used in Burkina Faso. Coming after the draft final report, this report presents comprehensive findings on the analytical method development and validation, formulation and stability testing for three strengths. Unlike the the previous report this has incorporated some of the comments and observation by the client.The stability of three formulations provided for individual dosing of FDC-LAN in the antiretroviral treatment of children covering the body weight range of 3 – 24 kg was tested under in-use conditions for a total storage of 6 weeks at 30 °C/75 % RH.

 Appearance, odour and the resuspensiblity did not change. No significant change of the content of the active ingredients was observed within the total test period.

 A stability of the formulations under in-use conditions in tropical climatic zones for 6 weeks may be accepted.

Generally it can be concluded that with respect to the results above the formulation is stable and can be used within the stability studied time, however the following should be taken into consideration during application:

  • The bottle containing the formulation should be sufficiently shaken by turning the bottle upside down to ensure redistribution before administration.
  • The product should be administered as soon as possible after the redistribution by shaking, at most not more than 10 minutes.
  • The photo stability of the product was not checked; hence it has to be kept away from the direct light.

Project 2: LTE

 

Project 3  EFV

 

 

 

 

Project 4 LT

 

Project 5 OMPR

 

 

 

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