Abstract
Objective: The main objective of this research work was to design, prepare and evaluate extended release (ER) tablets of anti-asthmatic drugs (salbutamol sulphate and theophylline) by direct compression method using diverse ratios of hydroxypropyl methylcellulose (HPMC K100M) and ethyl cellulose (EC) along with some other excipients.Methods: Extended-release matrix tablets of salbutamol sulphate and theophylline were successfully fabricated by direct compression method and coded the formulations as F1 to F7 depending on the ratios of modified polymers. The core tablets composed of hydrophilic polymers of various ratios that allow the discharge of drugs at a controlled rate after coming in contact with the aqueous medium. The designed tablets were subjected to various assessment parameters i.e. friability test, hardness test, drug content consistency and In vitro dissolution tests.Results: Prepared formulations were subjected to various assessment parameters and the findings obtained were within the prescribed limit. To perform the in vitro drug dissolution tests of fabricated tablets, the calibration plots of pure drugs using various solvents i.e. 0.1N HCl, phosphate buffer (pH 6.8) and distilled water were plotted. Dosage forms F1-F7 containing ethyl cellulose and HPMC K100M in various concentration demonstrates the prolonged medications discharge for up to 8 h, among these formulations, F6 shows 95.32±0.24 % for salbutamol sulphate and 94.19±0.39 % for theophylline release at the end of 8 h. This finding reveals that a particular window of concentrations of ethylcellulose and HPMC K100M was capable of providing prolonged drugs discharge.Conclusion: The results obtained in this research work clearly showed a promising potential of extended-release tablets containing a specific ratio of HPMC K100M and ethylcellulose as a release rate controlling polymers for effective treatment of asthma and chronic obstructive pulmonary diseases (COPD).
Highlights
Tablets have been the most preferred oral dosage form for the patients suffering from chronic diseases like bronchial asthma, chronic bronchitis and chronic obstructive pulmonary diseases (COPD) because of low-cost therapy and ease of administration [1, 2]
The present study aims to formulate, fabricate and evaluate the once-daily dose of extendedrelease matrix tablets using hydrophilic polymers, such as HPMC K100M and ethylcellulose in different ratios
Prepared formulations were subjected to various assessment parameters and the findings obtained were within the limits which are depicted in table 4
Summary
Tablets have been the most preferred oral dosage form for the patients suffering from chronic diseases like bronchial asthma, chronic bronchitis and chronic obstructive pulmonary diseases (COPD) because of low-cost therapy and ease of administration [1, 2]. The traditional tablets provide only a single and transient release of the drug. The pharmaceutical effect has only seen for the time duration in which the concentration of the drug remains within the therapeutic range that can be best achieved with ER tablets [3]. The significance of administering single-dose extended-release tablet that has discharged over an extended timeframe instead of multiple doses becomes the area of interest for the formulation designing scientists in the Pharmaceutical industry [4]. The terms sustained action, sustained discharge, controlled discharge, timed release, prolonged action, depot, extended action and repository formulations have been used to represent the novel drug delivery system (NDDS) and formulated to get an extended therapeutic effect by continuously discharging drug over a prolonged time period after administration of a single dose [6]. There might be several other reasons for the attractiveness of these dosage forms viz. provides enhanced bioavailability of medication, lessening in the recurrence of administration to extend the timeframe of effective blood levels, reduces the fluctuation of the peak-trough level and adverse effects and possibly enhances the particular distribution of the medication [7]
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