Comparative study of dissolution kinetics and permeability of a combination product of linagliptin and empagliflozin using Dissoflux™ methodology
Abstract
Introduction.
Combination products of linagliptin and empagliflozin are widely used for the treatment of type 2 diabetes mellitus. Both active substances belong to class III of the Biopharmaceutical Classification System (BCS), characterized by high solubility and low permeability. In the development of generic medicinal products, demonstration of therapeutic equivalence is critical; for this purpose, a comparative in vitro dissolution kinetics test is conducted within the framework of a biowaiver. However, for class III drugs, permeability is the rate-limiting step of absorption, necessitating the use of additional methodologies for its assessment.
Aim.
Comparative study of dissolution and permeability profiles of linagliptin and empagliflozin from film-coated tablets of a test combination product and a reference product using the Dissoflux™ methodology to substantiate the applicability of this approach in the assessment of biopharmaceutical equivalence.
Materials and methods.
The study objects were film-coated tablets of the test product (combination of linagliptin 2.5 mg and empagliflozin 10 mg) and a reference product of identical dosage. The comparative dissolution kinetics test (CDKT) was performed using a paddle apparatus (TrustE-8 basic, Electrolab, India) at 50 rpm in media with pH 1.2, 4.5 and 6.8 (volume 500 mL). Permeability studies were conducted using the Dissoflux™ system (Electrolab, India) in pH 6.8 medium (donor) and buffer solution with 0.05 % Tween 20…
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