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A novel metered dose transdermal spray formulation for oxybutynin.

Bakshi A, Bajaj A, Malhotra G, Madan M, Amrutiya N - Indian J Pharm Sci (2008)

Bottom Line: Diffusion studies of the optimized formulations through the semipermeable membrane showed the release of drug to the extent of almost 50% over a period of 24 h.Stability studies were conducted as per ICH guidelines and indicated that formulations were stable.Skin irritation studies were performed using rabbit as an animal model.

View Article: PubMed Central - PubMed

Affiliation: C. U. Shah College of Pharmacy, SNDT Women's University, Santacruz (W), Mumbai-400 049, India.

ABSTRACT
The objective of the present work was to develop a metered dose spray formulation for transdermal delivery of oxybutynin and to carry out the in vitro characterization of the optimized formulation. Oxybutynin release from a series of ethanol/acetone/methylal based formulations was assessed in vitro and the developed formulation was used for delivery from a metered dose spray. Various qualitative and quantitative parameters like spray pattern, particle size distribution, pH, evaporation time, pump seal efficiency test, average weight per metered dose, content per spray and content uniformity were evaluated. The different film forming agents were assessed and carbopol (0.5%) and lutrol (0.1%) were found to give good clarity of solution, evaporation rate, spray pattern and tackiness of the film. Diffusion studies of the optimized formulations through the semipermeable membrane showed the release of drug to the extent of almost 50% over a period of 24 h. Stability studies were conducted as per ICH guidelines and indicated that formulations were stable. Skin irritation studies were performed using rabbit as an animal model. The results obtained show that the metered dose transdermal spray formulation can be a promising and innovative therapeutic system for the transdermal administration of oxybutynin.

No MeSH data available.


Related in: MedlinePlus

Effect of film formers on in vitro release profile of oxybutynin Permeation of drug from reference solution (F1, –◆–) and from MDTS formulations containing Carbopol (F3, –■–) and Lutrol F-127 (F2, –▲–) as the film formers, respectively. Each value is mean±SEM of (n=3). The formulations F2 and F3 showed significantly higher release (P≤0.05) of drug as compared to formulation F1
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Figure 0001: Effect of film formers on in vitro release profile of oxybutynin Permeation of drug from reference solution (F1, –◆–) and from MDTS formulations containing Carbopol (F3, –■–) and Lutrol F-127 (F2, –▲–) as the film formers, respectively. Each value is mean±SEM of (n=3). The formulations F2 and F3 showed significantly higher release (P≤0.05) of drug as compared to formulation F1

Mentions: Permeation properties of the drug were characterized initially by conducting diffusion studies on the simple organic drug solution (F1). The diffusion studies from the optimized formulations F2 and F3 were also carried out over a period of 24 h. Rabbit ear skin was used as animal model skin, because of its similarity with human skin in vitro. As indicated from figs. 1 and 2, the release of oxybutynin from the optimized formulations was found to be 45-50% in 24h.


A novel metered dose transdermal spray formulation for oxybutynin.

Bakshi A, Bajaj A, Malhotra G, Madan M, Amrutiya N - Indian J Pharm Sci (2008)

Effect of film formers on in vitro release profile of oxybutynin Permeation of drug from reference solution (F1, –◆–) and from MDTS formulations containing Carbopol (F3, –■–) and Lutrol F-127 (F2, –▲–) as the film formers, respectively. Each value is mean±SEM of (n=3). The formulations F2 and F3 showed significantly higher release (P≤0.05) of drug as compared to formulation F1
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3040866&req=5

Figure 0001: Effect of film formers on in vitro release profile of oxybutynin Permeation of drug from reference solution (F1, –◆–) and from MDTS formulations containing Carbopol (F3, –■–) and Lutrol F-127 (F2, –▲–) as the film formers, respectively. Each value is mean±SEM of (n=3). The formulations F2 and F3 showed significantly higher release (P≤0.05) of drug as compared to formulation F1
Mentions: Permeation properties of the drug were characterized initially by conducting diffusion studies on the simple organic drug solution (F1). The diffusion studies from the optimized formulations F2 and F3 were also carried out over a period of 24 h. Rabbit ear skin was used as animal model skin, because of its similarity with human skin in vitro. As indicated from figs. 1 and 2, the release of oxybutynin from the optimized formulations was found to be 45-50% in 24h.

Bottom Line: Diffusion studies of the optimized formulations through the semipermeable membrane showed the release of drug to the extent of almost 50% over a period of 24 h.Stability studies were conducted as per ICH guidelines and indicated that formulations were stable.Skin irritation studies were performed using rabbit as an animal model.

View Article: PubMed Central - PubMed

Affiliation: C. U. Shah College of Pharmacy, SNDT Women's University, Santacruz (W), Mumbai-400 049, India.

ABSTRACT
The objective of the present work was to develop a metered dose spray formulation for transdermal delivery of oxybutynin and to carry out the in vitro characterization of the optimized formulation. Oxybutynin release from a series of ethanol/acetone/methylal based formulations was assessed in vitro and the developed formulation was used for delivery from a metered dose spray. Various qualitative and quantitative parameters like spray pattern, particle size distribution, pH, evaporation time, pump seal efficiency test, average weight per metered dose, content per spray and content uniformity were evaluated. The different film forming agents were assessed and carbopol (0.5%) and lutrol (0.1%) were found to give good clarity of solution, evaporation rate, spray pattern and tackiness of the film. Diffusion studies of the optimized formulations through the semipermeable membrane showed the release of drug to the extent of almost 50% over a period of 24 h. Stability studies were conducted as per ICH guidelines and indicated that formulations were stable. Skin irritation studies were performed using rabbit as an animal model. The results obtained show that the metered dose transdermal spray formulation can be a promising and innovative therapeutic system for the transdermal administration of oxybutynin.

No MeSH data available.


Related in: MedlinePlus