Optimization of metformin hydrochloride tablet by direct compression method using quality by design approach
By: Ozalp, Y
.
Contributor(s): Hourani, O. M.
Publisher: Mumbai Indian Journal of Pharmaceutical Science 2023Edition: Vol.85(4), Jul-Aug.Description: 1015-1024p.Subject(s): PHARMACEUTICSOnline resources: Click here
In:
Indian journal of pharmaceutical sciencesSummary: This study investigates the feasibility of directly compressing high doses of metformin hydrochloride despite
its poor compressibility. With regards to clearly outlined scientific principles, Quality by Design places a
great emphasis on the systematic development of products. However, it is highly helpful and essential to
understanding the causes and the interactions between the product components through a set of desired tests.
Metformin hydrochloride powder was compressed using flat faced Euro B punch of 15 mm diameter, using
Compaction Simulator (Stylcam 200R) at different compaction forces. Quality control tests were done on the
compressed tablets and were evaluated. Utilizing the quality by design method with Umetric MODDE software,
the necessity to develop direct compressible metformin hydrochloride was addressed. Tablet tensile strength,
friability and disintegration time were evaluated. The effect of formulation components and variables was
assessed. Binder types implemented as a singular unit or as combination showed their effect on formulation.
By evaluating the variations in formulations and optimization of metformin hydrochloride, a design space
was established through the identification of the critical process parameters, critical quality attributes, and
the risk assessment with the aid of Modde Pro 12.1 software. Design of experiment was applied for a better
understanding of the interactions between formulation variables and process parameters to achieve an
optimum formulation. Metformin hydrochloride was successfully developed by direct compression and the
simultaneous application of quality by design assisted in obtaining a robust formulation.
| Item type | Current location | Call number | Status | Date due | Barcode | Item holds |
|---|---|---|---|---|---|---|
Articles Abstract Database
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School of Pharmacy Archieval Section | Not for loan | 2024-0412 |
This study investigates the feasibility of directly compressing high doses of metformin hydrochloride despite
its poor compressibility. With regards to clearly outlined scientific principles, Quality by Design places a
great emphasis on the systematic development of products. However, it is highly helpful and essential to
understanding the causes and the interactions between the product components through a set of desired tests.
Metformin hydrochloride powder was compressed using flat faced Euro B punch of 15 mm diameter, using
Compaction Simulator (Stylcam 200R) at different compaction forces. Quality control tests were done on the
compressed tablets and were evaluated. Utilizing the quality by design method with Umetric MODDE software,
the necessity to develop direct compressible metformin hydrochloride was addressed. Tablet tensile strength,
friability and disintegration time were evaluated. The effect of formulation components and variables was
assessed. Binder types implemented as a singular unit or as combination showed their effect on formulation.
By evaluating the variations in formulations and optimization of metformin hydrochloride, a design space
was established through the identification of the critical process parameters, critical quality attributes, and
the risk assessment with the aid of Modde Pro 12.1 software. Design of experiment was applied for a better
understanding of the interactions between formulation variables and process parameters to achieve an
optimum formulation. Metformin hydrochloride was successfully developed by direct compression and the
simultaneous application of quality by design assisted in obtaining a robust formulation.
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