Abstract
Background: Now-a-day, there is a need to explore the concept of green chemistry in every field. Many existing conventional and novel drug delivery systems have problems related to green chemistry. Anewer natural dosage form pastilles were explored to overcome the existing limitations of the different dosage forms.
Objective: The present study aims to optimize the Glipizide (GPZ) matrix pastilles using waxy erodible polymers, integrating the concept of quality by design (QbD) and green chemistry.
Methods: The pastilles were formulated using the fabricated lab-scale pastillator. GPZ was used as a model drug. The concern related to the drug is low aqueous solubility and short variable half-life. The solubility of the drug was improved by formulating a complex between GPZ and chemically modified ß –cyclodextrin (β-CD) - hydroxypropyl-ß-cyclodextrin (HP-ß-CD). The complex was prepared using the kneading method. The complex was formulated and incorporated in different stoichiometric ratios of GPZ: complexing agent. Sustained-release pastille was formulated using Gelucire 43/01 (GC 43/01) as a release retardant polymer. The central composite design was used to obtain an optimum batch, using the amount of GC 43/01 and temperature as independent variables, while drug release at 2h, 6h, and 10h was chosen as dependent variables. The design batches were evaluated for post-and pre formulation parameters. An optimum formulation was evaluated for the influence of hydroalcoholic media on drug release.
Results: The complex formulated using HP-ß-CD (1:1) shown better solubility (36.5 mg/ml) and dissolution. The complex was incorporated in the pastilles with erodible polymer GC 43/01. The formulation was found robust with optimum pre and post-formulation parameters. An optimized batch was chosen from the design space of central composite design. The drug release of the optimized formulation was found 29.13%, 57.29% and 85.70% at 2, 6 and 10 hrs respectively, similar to the drug release of the marketed formulation. As the amount of alcohol increased from 5 to 40 %, the drug release also increased but did not show a dose dumping effect. It was due to the altered solubility of GPZ in alcohol.
Conclusion: The new formulation, Pastilles of GPZ were developed incorporating the waxy erodible polymer. Pastilles were capable of controlling drug release for up to 12 h. The amount of GC 43/01 and temperature had a significant effect on the formulation of GPZ sustained-release pastille. The newer approach of formulating pastilles might apply to the industry as it is an eco-friendly, single-step process with fewer excipients.
Keywords: Pastilles, green, chemistry, GPZ, GC 43/01, HP- ß -CD
Graphical Abstract
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