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 ۲ 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 ۴۰۷ was utilized as a polymer for immediate release. HPMC K۴M and EUDRAGIT RS ۱۰۰ for sustained release. Both layer blends were evaluated for precompression parameters. Using a ۳۲-factorial design, the influence of the variables like disintegration time and time required for ۱۰۰% drug release on Candesartan Cilexetil are measured.Results: The results show that HPMC forms a synergistic gel; controlling Pioglitazone medication release for ۲۰ hours. Batch F۶ with ۴۰ mg Eudragit produces a film around drug, limiting its release rate to ۲۴ hours. Candesartan Cilexetil immediate release layer demonstrated ۱۰۰% drug release at ۱۵ 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 ۲ diabetes.

Keywords:

Candesartan Cilexetil , Croscarmellose , mutual release dosage form , Design expert , Pioglitazone , Poloxamer ۴۰۷