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A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients
Published on: August 9, 2022
Solid-state compatibility screening of excipients suitable for development of indapamide sustained release
Packa Antovska1, Gjorgji Petruševski, Petre Makreski
1Research and Development, ALKALOID AD, Aleksandar Makedonski 12, 1000 Skopje, Republic of Macedonia. pantovska@alkaloid.com.mk
Pharmaceutical Development and Technology
|September 25, 2012
Summary
Solid-state compatibility of indapamide was assessed with polymers and excipients for sustained release formulations. Polyvinylpyrrolidone/polyvinyl acetate and sorbitol were found incompatible with indapamide.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
Background:
- Developing 24-hour sustained release indapamide formulations requires careful selection of polymers and excipients.
- Preformulation studies are crucial for identifying potential incompatibilities that could affect drug stability and release.
Purpose of the Study:
- To evaluate the solid-state compatibility of indapamide with various polymers and excipients.
- To identify suitable materials for a 24-hour sustained release indapamide solid-dosage formulation.
- To guide the selection of excipients and polymer matrices for indapamide drug development.
Main Methods:
- Differential Scanning Calorimetry (DSC) was used to screen for solid-state interactions.
- Fourier Transform Infrared Spectroscopy (FTIR) was employed to analyze chemical compatibility.
- Screening of polymer matrices and other excipients for compatibility with indapamide.
Main Results:
- Polyvinylpyrrolidone/polyvinyl acetate was identified as incompatible with indapamide.
- Sorbitol demonstrated incompatibility with indapamide.
- The study identified specific excipients to avoid in indapamide sustained release formulations.
Conclusions:
- Polyvinylpyrrolidone/polyvinyl acetate and sorbitol should be avoided in indapamide sustained release formulations due to incompatibility.
- The findings provide critical insights into the solid-state stability of indapamide binary systems.
- This research directs future development efforts for indapamide sustained release dosage forms.
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