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In vitro and in vivo evaluation of buccal bioadhesive films containing salbutamol sulphate. 2010

Sanjay Singh, and Rajeev Soni, and Manoj Kumar Rawat, and Achint Jain, and Shripad Bhimarao Deshpande, and Shripad Bheemrao Deshpande, and Sanjeev Kumar Singh, and Madaswamy Sona Muthu
Department of Pharmaceutics, Institute of Technology, Banaras Hindu University, Varanasi-221005, India. drsanjaysingh@rediffmail.com

The aim of present study was to prepare and evaluate buccal bioadhesive films of salbutamol sulphate (SS) for the treatment of asthma. The films were designed to release the drug for a prolonged period of time so as to reduce the frequency of administration of the available conventional dosage forms of SS. The different proportions of sodium carboxymethylcellulose (SCMC) and Carbopol 940P (CP 940P) were used for the preparation of films. Carbopol was used to incorporate the desired bioadhesiveness in the films. The films were prepared by solvent casting method and evaluated for bioadhesion, in vitro drug release and anti asthmatic effect (bronchoprotection) in histamine induced bronchospasm of guinea pigs. In vitro drug release from the film was determined using a modified Franz diffusion cell while bioadhesiveness was evaluated with a modified two-arm balance using guinea pig buccal mucosa as a model tissue. Films containing SCMC : CP 940P ratio of 76 : 24 was found to be the best with moderate swelling along with favorable bioadhesion force and in vitro drug release. The drug release mechanism was found to follow non-Fickian diffusion as release mechanism. The prolonged in vivo effect (bronchoprotection) obtained from the buccal bioadhesive film of SS administered via buccal route may improve the treatment of asthmatic disorders by reducing the frequency of administration which is associated with the tolerance effect of SS. Additionally for the clinical benefit, it is also expected to reduce the major adverse effects of SS such as tachycardia and arrhythmias via buccal absorption.

UI MeSH Term Description Entries
D002266 Carboxymethylcellulose Sodium A cellulose derivative which is a beta-(1,4)-D-glucopyranose polymer. It is used as a bulk laxative and as an emulsifier and thickener in cosmetics and pharmaceuticals and as a stabilizer for reagents. Carboxymethyl Cellulose,Carboxymethylcellulose,Aquacel,Aquaplast,Carmellose Sodium,Cellolax,Cethylose,Croscarmellose Sodium,Polycell,Ruspol,Sodium Carboxymethylcellulose,Carboxymethylcellulose, Sodium,Cellulose, Carboxymethyl,Sodium, Carboxymethylcellulose,Sodium, Carmellose,Sodium, Croscarmellose
D002626 Chemistry, Pharmaceutical Chemistry dealing with the composition and preparation of agents having PHARMACOLOGIC ACTIONS or diagnostic use. Medicinal Chemistry,Chemistry, Pharmaceutic,Pharmaceutic Chemistry,Pharmaceutical Chemistry,Chemistry, Medicinal
D004058 Diffusion The tendency of a gas or solute to pass from a point of higher pressure or concentration to a point of lower pressure or concentration and to distribute itself throughout the available space. Diffusion, especially FACILITATED DIFFUSION, is a major mechanism of BIOLOGICAL TRANSPORT. Diffusions
D006168 Guinea Pigs A common name used for the genus Cavia. The most common species is Cavia porcellus which is the domesticated guinea pig used for pets and biomedical research. Cavia,Cavia porcellus,Guinea Pig,Pig, Guinea,Pigs, Guinea
D000180 Acrylic Resins Polymers of high molecular weight which are derived from acrylic acid, methacrylic acid or other related compounds and are capable of being molded and then hardened to form useful components. Acrylic Resin,Resin, Acrylic,Resins, Acrylic
D000268 Adhesiveness A property of the surface of an object that makes it stick to another surface. Adhesivenesses
D000278 Administration, Buccal Administration of a soluble dosage form between the cheek and gingiva. It may involve direct application of a drug onto the buccal mucosa, as by painting or spraying. Buccal Drug Administration,Drug Administration, Buccal,Buccal Administration,Administration, Buccal Drug,Administrations, Buccal,Administrations, Buccal Drug,Buccal Administrations,Buccal Drug Administrations,Drug Administrations, Buccal
D000420 Albuterol A short-acting beta-2 adrenergic agonist that is primarily used as a bronchodilator agent to treat ASTHMA. Albuterol is prepared as a racemic mixture of R(-) and S(+) stereoisomers. The stereospecific preparation of R(-) isomer of albuterol is referred to as levalbuterol. Salbutamol,2-t-Butylamino-1-(4-hydroxy-3-hydroxy-3-hydroxymethyl)phenylethanol,Albuterol Sulfate,Proventil,Sultanol,Ventolin
D000818 Animals Unicellular or multicellular, heterotrophic organisms, that have sensation and the power of voluntary movement. Under the older five kingdom paradigm, Animalia was one of the kingdoms. Under the modern three domain model, Animalia represents one of the many groups in the domain EUKARYOTA. Animal,Metazoa,Animalia
D001249 Asthma A form of bronchial disorder with three distinct components: airway hyper-responsiveness (RESPIRATORY HYPERSENSITIVITY), airway INFLAMMATION, and intermittent AIRWAY OBSTRUCTION. It is characterized by spasmodic contraction of airway smooth muscle, WHEEZING, and dyspnea (DYSPNEA, PAROXYSMAL). Asthma, Bronchial,Bronchial Asthma,Asthmas

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