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Design optimization and in vitro-in vivo evaluation of orally dissolving strips of clobazam.

Bala R, Khanna S, Pawar P - J Drug Deliv (2014)

Bottom Line: Formulation (F6) was selected by the Design-expert software which exhibited DT (24 sec), TS (2.85 N/cm(2)), and in vitro drug release (96.6%).Statistical evaluation revealed no significant difference between the bioavailability parameters of the test film (F6) and the reference product.The mean ratio values (test/reference) of C max (95.87%), t max (71.42%), AUC0-t (98.125%), and AUC0-∞ (99.213%) indicated that the two formulae exhibited comparable plasma level-time profiles.

View Article: PubMed Central - PubMed

Affiliation: Chitkara College of Pharmacy, Chandigarh-Patiala National Highway, Rajpura, Patiala, Punjab 140 401, India.

ABSTRACT
Clobazam orally dissolving strips were prepared by solvent casting method. A full 3(2) factorial design was applied for optimization using different concentration of film forming polymer and disintegrating agent as independent variable and disintegration time, % cumulative drug release, and tensile strength as dependent variable. In addition the prepared films were also evaluated for surface pH, folding endurance, and content uniformity. The optimized film formulation showing the maximum in vitro drug release, satisfactory in vitro disintegration time, and tensile strength was selected for bioavailability study and compared with a reference marketed product (frisium5 tablets) in rabbits. Formulation (F6) was selected by the Design-expert software which exhibited DT (24 sec), TS (2.85 N/cm(2)), and in vitro drug release (96.6%). Statistical evaluation revealed no significant difference between the bioavailability parameters of the test film (F6) and the reference product. The mean ratio values (test/reference) of C max (95.87%), t max (71.42%), AUC0-t (98.125%), and AUC0-∞ (99.213%) indicated that the two formulae exhibited comparable plasma level-time profiles.

No MeSH data available.


Related in: MedlinePlus

DSC thermogram of (a) clobazam, (b) F6, and (c) physical blend of clobazam, PVA, and SSG.
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fig2: DSC thermogram of (a) clobazam, (b) F6, and (c) physical blend of clobazam, PVA, and SSG.

Mentions: DSC thermograms of clobazam (pure drug), PVA (polymer), clobazam and SSG, and clobazam loaded orally dissolving strip as shown in Figures 2(a), 2(b), and 2(c) illustrated a sharp endothermic peak corresponding to the melting of crystalline clobazam at 180°C. The melting endothermic peak of clobazam was not observed in the drug loaded PVA orally dissolving strip. This indicates that clobazam was uniformly dispersed and present in an amorphous state in the polymeric matrix.


Design optimization and in vitro-in vivo evaluation of orally dissolving strips of clobazam.

Bala R, Khanna S, Pawar P - J Drug Deliv (2014)

DSC thermogram of (a) clobazam, (b) F6, and (c) physical blend of clobazam, PVA, and SSG.
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4195261&req=5

fig2: DSC thermogram of (a) clobazam, (b) F6, and (c) physical blend of clobazam, PVA, and SSG.
Mentions: DSC thermograms of clobazam (pure drug), PVA (polymer), clobazam and SSG, and clobazam loaded orally dissolving strip as shown in Figures 2(a), 2(b), and 2(c) illustrated a sharp endothermic peak corresponding to the melting of crystalline clobazam at 180°C. The melting endothermic peak of clobazam was not observed in the drug loaded PVA orally dissolving strip. This indicates that clobazam was uniformly dispersed and present in an amorphous state in the polymeric matrix.

Bottom Line: Formulation (F6) was selected by the Design-expert software which exhibited DT (24 sec), TS (2.85 N/cm(2)), and in vitro drug release (96.6%).Statistical evaluation revealed no significant difference between the bioavailability parameters of the test film (F6) and the reference product.The mean ratio values (test/reference) of C max (95.87%), t max (71.42%), AUC0-t (98.125%), and AUC0-∞ (99.213%) indicated that the two formulae exhibited comparable plasma level-time profiles.

View Article: PubMed Central - PubMed

Affiliation: Chitkara College of Pharmacy, Chandigarh-Patiala National Highway, Rajpura, Patiala, Punjab 140 401, India.

ABSTRACT
Clobazam orally dissolving strips were prepared by solvent casting method. A full 3(2) factorial design was applied for optimization using different concentration of film forming polymer and disintegrating agent as independent variable and disintegration time, % cumulative drug release, and tensile strength as dependent variable. In addition the prepared films were also evaluated for surface pH, folding endurance, and content uniformity. The optimized film formulation showing the maximum in vitro drug release, satisfactory in vitro disintegration time, and tensile strength was selected for bioavailability study and compared with a reference marketed product (frisium5 tablets) in rabbits. Formulation (F6) was selected by the Design-expert software which exhibited DT (24 sec), TS (2.85 N/cm(2)), and in vitro drug release (96.6%). Statistical evaluation revealed no significant difference between the bioavailability parameters of the test film (F6) and the reference product. The mean ratio values (test/reference) of C max (95.87%), t max (71.42%), AUC0-t (98.125%), and AUC0-∞ (99.213%) indicated that the two formulae exhibited comparable plasma level-time profiles.

No MeSH data available.


Related in: MedlinePlus