Development of a Bilayer Mutual Tablet of Candesartan and Pioglitazone for Diabetic-Hypertensive Patients

Background: Diabetes and hypertension are related illnesses that often coexist. Angiotensin receptor blockers like candesartan are typically used to treat Hypertension. A thiazolidinedione-type diabetes drug, pioglitazone helps those with type 2 diabetes manage their elevated blood sugar levels. The absence of a combination dose form on the market today may have industrial implications. Regulatory bodies advocate the use of a Quality by Design (QbD) methodology during the product development process to ensure product quality. Objective: The current study strives to develop an oral bilayer matrix tablet of candesartan Cilexetil and pioglitazone increasing patient compliance and decreasing the frequency of doses for treating hypertensive cardiovascular damage. Method: Poloxamer 407 was utilized as a polymer for immediate release. HPMC K4M and EUDRAGIT RS 100 for sustained release. Both layer blends were evaluated for precompression parameters. Using a 32-factorial design, the influence of the variables like disintegration time and time required for 100% drug release on Candesartan Cilexetil are measured. Results: The results show that HPMC forms a synergistic gel; controlling Pioglitazone medication release for 20 hours. Batch F6 with 40 mg Eudragit produces a film around drug, limiting its release rate to 24 hours. Candesartan Cilexetil immediate release layer demonstrated 100% drug release at 15 minutes. Conclusion: Quality by Design (QbD) approach offers an effective, efficient framework to incorporate Candesartan Cilexetil and Pioglitazone in a fixed dose bilayer tablet as this combo is beneficial for individuals who suffer from hypertension and type 2 diabetes.