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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

Strain-stress curves of the clobazam optimized ODF F6.
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Related In: Results  -  Collection


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fig3: Strain-stress curves of the clobazam optimized ODF F6.

Mentions: Addition of SSG affects tensile strength and % elongation; higher concentration of SSG increases thickness and crystallinity of the film, which causes decrease in the tensile strength and % elongation. The stress strain curve of optimized ODF formulation F6 is shown in Figure 3.


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

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

Strain-stress curves of the clobazam optimized ODF F6.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

fig3: Strain-stress curves of the clobazam optimized ODF F6.
Mentions: Addition of SSG affects tensile strength and % elongation; higher concentration of SSG increases thickness and crystallinity of the film, which causes decrease in the tensile strength and % elongation. The stress strain curve of optimized ODF formulation F6 is shown in Figure 3.

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