Design and Evaluation of Losartan Potassium Sustained and Hydrochlorothiazide Immediate Release Formulation (Research Article)

Author(s): Bimal Debbarma* and Chandra Kishore Tyagi

Abstract: Regioselective dual components technology is utilized to develop sustain release and immediate release formulation for a single drug or combination of drugs. The main objective of the present research work was to prepare dual components of hydrochlorothiazide and losartan potassium in separate layers for desired release patterns and thus maximize the efficacy of both drugs in combination for the effective treatment of hypertension. In the dual component capsule, an immediate release layer of hydrochlorothiazide was prepared by dry granulation method using crospovidone as super disintegrants, and sustain release layer of losartan potassium microbeads was prepared using sodium alginate adopting ionotropic gelation method using calcium chloride and blend of chitosan employing ionic and covalent cross-linking method. Preformulation studies were performed before compression. The microbeads were evaluated for drug entrapment efficiency, swelling index, and in-vitro drug release studies. The drug excipients compatibility studies were carried out using ATR and DSC. Spectra revealed that there was no interaction found between drugs and excipients used in the formulations. All the pre-compression studies revealed that the results were found to be within the official limits. In-vitro release studies reveal that the hydrochlorothiazide immediate release layer was found to be 98.41% within 120 minutes and the losartan potassium sustained release layer was 99.14% at the end of 12 hrs. Release kinetics showed good linearity by best fitting into the Higuchi model and stability studies showed no changes after exposing to accelerated conditions for 1 month for physical characteristics and in-vitro drug release studies. From the above study, it can be concluded that the prepared region-selective dual component capsule achieved the objective of the research work in treating hypertension.

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