Abstract
Objective: The purpose of this study was to design and formulate mucoadhesive buccal patches of sodium cromoglycate (SCG) as an alternative way to overcome its poor oral absorption and short half-life.Methods: Mucoadhesive patches were prepared by solvent casting technique using cellulose acetate butyrate (CAB) alone or in combination with mucoadhesive polymers like SCMC (sodium carboxymethyl cellulose), HPMC 100M (hydroxyl propyl methyl cellulose) and Cbp934P (carbopol) in different concentrations. The successful patches were evaluated for thickness, weight variation, folding endurance, tensile strength, drug content, surface pH, moisture uptake, swelling percentage, mucoadhesion strength, residence time, in vitro release study, ex vivo permeation and in vivo pharmacokinetic studies.Results: The thickness of all prepared patches ranged from 0.210±0.006 to0.355±0.012, folding endurance was more than 300, weight variation did not exceed 0.179±0.015, tensile strength and % elongation ranged from 6.4±0.018 to 13.1±0.024, and from 30.4±0.88 to 53.4±0.78respectively. The swelling percentage after one hour was from 20.8±0.99 to 53.2±1.5. pH of all prepared patches did not exceed 6.8, the drug content was about 99 to 101%, moisture uptake did not exceed 10%. Mucoadhesion strength and residence time ranged from 17.2±0.14 to 51.2±0.26, and from 3.35±0.25 to 7.45±0.28 respectively. The cumulative release percentage of SCG was in the following descending order CAB>CAB with Cbp934P>CAB with HPMC>CAB with SCMC. The optimized patch (F9) decreased the Cmax and increased Tmax compared to the parenteral solution.Conclusion: It can be concluded that mucoadhesive buccal patch is a promising dosage form to prolong the release of SCG and enhance its poor oral bioavailability.
Highlights
Oral drug delivery remains the most common and preferred route for delivery of many drugs, it suffers from several important drawbacks such as enzymatic degradation along the gastrointestinal tract, first pass metabolism, delayed onset of absorption and sometimes poor absorption
Mucoadhesive buccal patches are more recent dosage form which is designed to give systemic or local drug delivery and fabricated to overcome the short residence time of oral gel which is washed by saliva [5] and discomfort of solid dosage forms like tablets
The solvent casting technique was used for the preparation of sodium cromoglycate (SCG) mucoadhesive patch [9,10,11,12]
Summary
Oral drug delivery remains the most common and preferred route for delivery of many drugs, it suffers from several important drawbacks such as enzymatic degradation along the gastrointestinal tract, first pass metabolism, delayed onset of absorption and sometimes poor absorption These defects necessitate the importance of designing alternative dosage forms to be administered through alternative routes such as pulmonary, transdermal, ocular, rectal, vaginal and buccal. Sodium cromoglycate is a mast cell stabilizer that inhibits the release of inflammatory mediators and prevents the immediate onset and delayed onset asthma [6, 7] It suffers from poor oral absorption, which is found to be 0.5% of the total administered dose and short plasma half-life which is 60-90 min [8]. This research work aims to design, formulate and evaluate mucoadhesive buccal patches of SCG to overcome its poor oral absorption and prolonged its release and enhances its bioavailability
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