Limits...
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

Means of plasma concentrations and time profiles of clobazam from (F6) ODF and marketed formulation (frisium5) mean ± SD n = 3.
© Copyright Policy - open-access
Related In: Results  -  Collection


getmorefigures.php?uid=PMC4195261&req=5

fig10: Means of plasma concentrations and time profiles of clobazam from (F6) ODF and marketed formulation (frisium5) mean ± SD n = 3.

Mentions: The mean clobazam plasma concentration time profiles for the prepared orally dissolving strip and the marketed tablets are shown in Figure 10. The statistical comparison of Cmax⁡, AUC0−t, and AUC0−∞ indicated no significant difference between the two treatments (test and reference marketed tablets). The 90% confidence intervals for the mean ratio (test/reference) of Cmax⁡, AUC0−t, and AUC0−∞ were 95.87%, 98.12%, and 99.21%, respectively, and are shown in Table 10, while the acceptable range is 80–125% for AUC0−t and AUC0−∞, and 70–143% for Cmax⁡, as proposed by the FDA [37].


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

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

Means of plasma concentrations and time profiles of clobazam from (F6) ODF and marketed formulation (frisium5) mean ± SD n = 3.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

fig10: Means of plasma concentrations and time profiles of clobazam from (F6) ODF and marketed formulation (frisium5) mean ± SD n = 3.
Mentions: The mean clobazam plasma concentration time profiles for the prepared orally dissolving strip and the marketed tablets are shown in Figure 10. The statistical comparison of Cmax⁡, AUC0−t, and AUC0−∞ indicated no significant difference between the two treatments (test and reference marketed tablets). The 90% confidence intervals for the mean ratio (test/reference) of Cmax⁡, AUC0−t, and AUC0−∞ were 95.87%, 98.12%, and 99.21%, respectively, and are shown in Table 10, while the acceptable range is 80–125% for AUC0−t and AUC0−∞, and 70–143% for Cmax⁡, as proposed by the FDA [37].

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