[Pharmaceutical technology of Tensiomin]

Area of Science:

• Pharmaceutical Chemistry
• Solid-State Chemistry

Context:

• Captopril, an active pharmaceutical ingredient in Tensiomin tablets, requires understanding of its physicochemical properties for effective formulation.
• Two polymorphic forms of captopril exist, with Form I being therapeutically relevant due to its higher melting point.

Purpose:

• To evaluate the physical chemical properties, stability, and incompatibilities of captopril.
• To assess the impact of formulation variables and storage conditions on captopril stability and tablet performance.
• To determine if Tensiomin tablets meet United States Pharmacopeia (USP) standards.

Summary:

• Captopril exhibits optimal stability in solutions below pH 4, with accelerated degradation by metallic ions (Cu, Fe) and air humidity in solid form.
• Incompatibility was noted with stearic acid and sodium-carboxymethyl-starch, and captopril showed lamination tendency under high compaction pressure.
• Tensiomin tablets manufactured using direct tabletting met USP dissolution rate requirements, irrespective of tablet breaking strength.

Impact:

• Establishes critical parameters for captopril formulation and storage to ensure drug stability.
• Provides insights into potential tabletting challenges and excipient interactions.
• Confirms the quality and stability of Tensiomin tablets across various dosages, meeting stringent pharmacopeial standards.