Abstract
Purpose: To develop floating matrix tablets of salbutamol sulphate using ethyl cellulose and acrycoat S-100 as polymers, and sodium bicarbonate, citric acid and tartaric acid as gas generating agents. Methods: Twenty four formulations were prepared and segregated into four major categories, A to D. The floating tablets were prepared by wet granulation technique, and the granules were compressed at a pressure of 50 kg/cm2. The tablets contained drug, ethyl cellulose and Acrycoat S-100 (as releaseretarding polymers), sodium bicarbonate, citric acid and tartaric acid (as gas formers) as well as various additives. The tablets were made by wet granulation technique. The formulations were evaluated for in vitro buoyancy, dissolution and in vitro drug release. Results: All the formulations fulfilled the essential requirements for good floating systems. Formulation F8, containing citric acid and sodium bicarbonate, showed lower lag time and longer floating duration than the formulations containing only sodium bicarbonate. Formulation F8.2 (which contained citric and tartaric acid at a ratio of 1:1) showed longer floating duration (9 h) than F8. As the concentration of sodium bicarbonate increased in formulation F8.2, drug release decreased while floating duration increased.Conclusion: Of all the 24 formulations, the one containing tartaric acid and citric acid in ratio 1:3 and 12 mg sodium bicarbonate showed the highest floating duration and least lag time.Keywords: Salbutamol sulphate, Ethyl cellulose, Acrycoat S-100, Sodium bicarbonate, Citric acid, Tartaric acid
Highlights
The high cost involved in the development of a new drug molecule has caused many pharmaceutical companies to divert greater attention to the development of new drug delivery systems
While the system floats over the gastric contents, the drug is released slowly at the desired rate, which results in increased gastric retentive time and reduced fluctuation in plasma drug concentration [2]
The drug selected for this study, salbutamol sulphate, is a sympathomimetic amine used as a bronchodilator in the treatment of reversible bronchospasm
Summary
The high cost involved in the development of a new drug molecule has caused many pharmaceutical companies to divert greater attention to the development of new drug delivery systems. The tablet incorporated the drug (salbutamol sulphate), ethyl cellulose and Acrycoat S-100 as matrix formers, and sodium bicarbonate and citric acid as gas generating agents. The dried granules retained on a 500 μm mesh were mixed with talc and magnesium stearate and compressed into tablets using an automated single punch tabletting machine, keeping tablet hardness at 4 – 5 kg/cm and weight at 100 ± 5 mg This formulations series (F8, F8.1 and F8.2) was prepared to improve the floating capability of the best formulation in A series, namely, F8, by incorporating an additional floating agent (tartaric acid) as well as its combination with citric acid. When sodium bicarbonate was combined with citric acid, the release of CO2 increased, lowering floating lag time to a range varying from 30 to 70 s for formulations F4 to F9 (Table 1). F8 was considered the most suitable for optimization study
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