Effects of various polymers on dissolution improvement of fabricated amorphous clonazepam solid dispersion-an in vitro study

The 1,4-benzodiazepine derivative clonazepam (Biopharmaceutics Classification System [BCS] class ii) drug, which is a hypnotic and tranquiliser, is almost completely insoluble in water and lipophilic in nature. Since traditional dosage forms typically have a number of drawbacks, solid dispersion (SD) technology can be helpful in improving the way that pharmaceuticals dissolve, absorb and work therapeutically in dosage forms. Our study's objective is to create an SD formulation of the poorly water soluble medication clonazepam (CLZ) with the hydrophilic polymers PEG 4000 and PEG 6000. The main advantages of using water-soluble polymers as carriers are their low toxicity and wide applicability for the majority of medications. Using physical mixing and SD techniques, the polymers were employed with the medication CLZ in varying ratios (1:2, 1:4, 1:6). The production yield, drug content analysis and cumulative drug release of the produced formulations were evaluated. At 60 minutes, only the pure drug exhibited 51% of release. However, the solubility of the medication is significantly increased when hydrophilic polymer is added. With a better drug release by the polymer PEG 6000 and an 80.19% in vitro drug release, the formulation KSD9 showed promise. Furthermore, the other polymer exhibited 59.11% in kneading method and 57.08% in fusion method respectively. Hence the greater carrier content and the prevention of crystallinity in the dispersion, the binary SD produced using various techniques significantly increases the drug's solubility.