COMPARATIVE STUDY OF TELMISARTAN TABLETS IN STANDARD AND GENERIC DOSAGE FORMS

Registration ID: IJNRD_328760

Published ID: IJNRD2610010

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Saurabh Milind Bansode, Rupesh Bhagwan Sonune, Rushikesh Gajanan Narwade, Rushikesh Purushottam Tayde, Prof. Vishal Hule

Telmisartan; angiotensin II receptor blocker; generic tablets; Micardis; dissolution; bioequivalence; pharmaceutical equivalence; critical material attributes; quality by design; biorelevant dissolution.

Telmisartan is a non-peptide angiotensin II receptor blocker that selectively antagonizes the angiotensin II type 1 (AT1) receptor. By preventing angiotensin II from activating AT1 receptors, it reduces vasoconstrictor and aldosterone-secreting effects of the renin–angiotensin system. The FDA prescribing information describes telmisartan as having substantially greater affinity for AT1 than AT2 receptors and notes that its mechanism does not depend on inhibition of angiotensin- converting enzyme. [1] The clinical use of telmisartan makes consistent dosage-form performance important because the active ingredient must be liberated from the tablet, dissolve in gastrointestinal fluid, become available for absorption and subsequently reach systemic circulation. From a formulation-development perspective, telmisartan is a useful model for studying poorly water-soluble immediate- release products. The drug is practically insoluble in water and over much of the pH range encountered in aqueous media, while becoming more soluble under strongly basic conditions. [1] Published formulation studies have therefore classified telmisartan as a BCS Class II compound, characterized by low aqueous solubility with comparatively high permeability. [2,3] For such compounds, dissolution can become a rate-limiting step in oral absorption, so apparently small changes in particle size, solid-state form, excipient functionality or local formulation pH can influence product performance. The comparison of reference and generic tablets is more complex than verifying the labeled dose. Pharmaceutical equivalence concerns the identity, strength, dosage form and route of administration, whereas bioequivalence addresses the rate and extent to which the active ingredient becomes available systemically under defined study conditions. In-vitro dissolution provides an important mechanistic and quality-control tool, but it is not automatically interchangeable with an in- vivo bioequivalence conclusion. The original manuscript correctly emphasizes that physical testing, assay, dissolution and pharmacokinetic evidence are complementary rather than redundant. filecite turn0file0 L41-L43 Rationale for the expanded review The initial nine- page manuscript summarized the principal comparative literature but left several areas suitable for deeper treatment: drug physicochemistry, mechanisms by which excipients alter dissolution and absorption, analytical methods, interpretation of f₂, biorelevant dissolution, quality-by-design, stability, regulatory concepts and future formulation strategies. This expanded version retains the original scope and terminology while integrating additional peer-reviewed and regulatory evidence through 2026.

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Saurabh Milind Bansode, Rupesh Bhagwan Sonune, Rushikesh Gajanan Narwade, Rushikesh Purushottam Tayde, & Prof. Vishal Hule (October-2026). COMPARATIVE STUDY OF TELMISARTAN TABLETS IN STANDARD AND GENERIC DOSAGE FORMS. INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT, 11(10), a92-a101. https://ijnrd.org/papers/IJNRD2610010.pdf

Volume 11 Issue 10, October-2026

Pages : a92-a101

Paper Reg. ID: IJNRD_328760

Published Paper Id: IJNRD2610010

Research Area: Pharmacy All

Author Type: Indian Author

Country: Buldhana, Maharashtra , India

Published Paper PDF: https://ijnrd.org/papers/IJNRD2610010.pdf

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