Get 20M+ Full-Text Papers For Less Than $1.50/day. Start a 14-Day Trial for You or Your Team.

Learn More →

Quality by Design Approach in the Formulation of Glibenclamide Mucoadhesive Buccal Films

Quality by Design Approach in the Formulation of Glibenclamide Mucoadhesive Buccal Films Abstract Glibenclamide, an oral hypoglycemic BCS class II drug that gets completely metabolized in the liver, serves as a suitable candidate for buccal drug delivery. The study aims to formulate and evaluate mucoadhesive buccal films (MBF) of Glibenclamide by Quality by Design approach to ensure the quality of a developed product. Initially, Plackett Burman Design was used as a screening method to determine the factors affecting the characteristics of the MBF. The selected factors were further evaluated using 32 full factorial design for confirming the effect of these variables. Responses like Drug release, mucoadhesion time, permeability were considered the main Critical Quality Attributes. The film was evaluated for swelling, mucoadhesion, folding endurance, permeability, drug release. Contour and surface response plots were used to determine the design space (DS). The formulated film gave a robust design within 1.3-1.7 % for HPMC K 15M and 0.5-1.5 % for glycerin. The optimized formulation prepared within the DS showed in-vitro drug release (80.11%), mucoadhesive strength (60.3 g), and ex-vivo permeation (82.85 %), which lies within pre-determined full ranges of Quality Target Product Profile (QTTP). The optimized formulation within the DS was in good agreement with QTPP, which ensures the accuracy and robustness of the formulation. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Analytical Chemistry Letters Taylor & Francis

Quality by Design Approach in the Formulation of Glibenclamide Mucoadhesive Buccal Films

Download PDF

Quality by Design Approach in the Formulation of Glibenclamide Mucoadhesive Buccal Films

Abstract

Abstract Glibenclamide, an oral hypoglycemic BCS class II drug that gets completely metabolized in the liver, serves as a suitable candidate for buccal drug delivery. The study aims to formulate and evaluate mucoadhesive buccal films (MBF) of Glibenclamide by Quality by Design approach to ensure the quality of a developed product. Initially, Plackett Burman Design was used as a screening method to determine the factors affecting the characteristics of the MBF. The selected factors were...
Loading next page...
 
/lp/taylor-francis/quality-by-design-approach-in-the-formulation-of-glibenclamide-cbpG2cn0TP
Publisher
Taylor & Francis
Copyright
© 2021 Har Krishan Bhalla & Sons
ISSN
2230-7532
eISSN
2229-7928
DOI
10.1080/22297928.2021.1938217
Publisher site
See Article on Publisher Site

Abstract

Abstract Glibenclamide, an oral hypoglycemic BCS class II drug that gets completely metabolized in the liver, serves as a suitable candidate for buccal drug delivery. The study aims to formulate and evaluate mucoadhesive buccal films (MBF) of Glibenclamide by Quality by Design approach to ensure the quality of a developed product. Initially, Plackett Burman Design was used as a screening method to determine the factors affecting the characteristics of the MBF. The selected factors were further evaluated using 32 full factorial design for confirming the effect of these variables. Responses like Drug release, mucoadhesion time, permeability were considered the main Critical Quality Attributes. The film was evaluated for swelling, mucoadhesion, folding endurance, permeability, drug release. Contour and surface response plots were used to determine the design space (DS). The formulated film gave a robust design within 1.3-1.7 % for HPMC K 15M and 0.5-1.5 % for glycerin. The optimized formulation prepared within the DS showed in-vitro drug release (80.11%), mucoadhesive strength (60.3 g), and ex-vivo permeation (82.85 %), which lies within pre-determined full ranges of Quality Target Product Profile (QTTP). The optimized formulation within the DS was in good agreement with QTPP, which ensures the accuracy and robustness of the formulation.

Journal

Analytical Chemistry Letters – Taylor & Francis

Published: Jul 4, 2021

Keywords: Mucoadhesive buccal films; Glibenclamide; Quality by Design; Plackett Burman design

References

  • The use of mucoadhesive polymers in buccal drug delivery
  • Buccal bioadhesive drug delivery- A promising option for orally less efficient drugs
  • Physicochemical characterization of five glyburide powders: A BCS based approach to predict oral absorption
  • Manufacture and characterization of mucoadhesive buccal films
  • Formulation and Characterization of Fast Dissolving Buccal Films: A Review
  • Development and evaluation of buccal film containing antihypertensive agent
  • Fluconazole Mucoadhesive Buccal Films: In Vitro/In Vivo Performance
  • Comparative Evaluation of Porous Versus Nonporous Mucoadhesive Films as Buccal Delivery System of Glibenclamide. AAPS Pharm
  • Buccoadhesive gels of Glibenclamide: a means for achieving enhanced bioavailability
  • Solubility of sparingly-soluble ionizable drugs
  • Glibenclamide, metformin, and insulin for the treatment of gestational diabetes: a systematic review and meta-analysis
  • Formulation and evaluation of matrix type transdermal patches of Glibenclamide
  • Glibenclamide Nanocrystals in a Biodegradable Chitosan Patch for Transdermal Delivery: Engineering, Formulation, and Evaluation
  • Formulation development in vitro and in vivo evaluation of membrane controlled transdermal system of Glibenclamide
  • Calcium alginate/gum Arabic beads containing glibenclamide: Development and in vitro characterization
  • Development of solid lipid nanoparticles as carriers for improving oral bioavailability of Glibenclamide
  • Development and Characterization of Nanoparticles of Glibenclamide by Solvent Displacement Method
  • Application of Plackett-Burman screening design for preparing Glibenclamide nanoparticles for dissolution enhancement
  • Formulation and In-Vitro Evaluation of Sustained Released Glibenclamide Microspheres
  • Evaluation of Glibenclamide microspheres for sustained release
  • Formulation and characterization of glibenclamide and quercetin-loaded chitosan nanogels targeting skin permeation
  • Formulation and Evaluation of Buccal Film of Glimepiride
  • Preparation and characterization of insulin chitosan-nanoparticles loaded in buccal films
  • ICH Harmonized
  • Quality by Design (QbD) approach used in development of pharmaceuticals
  • Solid dispersion as strategy to improve oral bioavailability to of poor water soluble drugs
  • A quality by design (QbD) case study on enteric coated pellets: Screening of critical variables and establishment of design space at laboratory scale
  • Quality by design approach for optimizing the formulation and physical properties of extemporaneously prepared Orodispersible films
  • Formulation and evaluation of glibenclamide solid dispersion using different methods
  • Development of mucoadhesive films for buccal administration of ibuprofen
  • Formulation and in- vitro evaluation of mucoadhesive buccal films of Glibenclamide
  • Development and validation of UV spectrophotometric method for estimation of Glibenclamide in bulk and Pharmaceutical dosage forms
  • Design evaluation and in vitro - in vivo correlation of Glibenclamide buccoadhesive films
  • Mucoadhesive buccal films of Glibenclamide: development and evaluation
  • Preparation and Evaluation of Glibenclamide Slow Release Mucoadhesive Buccal Film
  • Enhancement of drug dissolution of Glibenclamide using solid dispersion technique
  • Solid Dispersions: An Approach to Enhance the Bioavailability of Poorly Water-Soluble Drugs
  • Buccal penetration enhancers-how do they really work
  • Preparation and evaluation of buccal films of clotrimazole for oral candida infections