Formulation and in vitro-in vivo evaluation of rapidly disintegrating tablets of salbutamol and prednisolone
Dissertant
Thesis advisor
University
Omdurman Islamic University
Faculty
Faculty of Pharmacy
University Country
Sudan
Degree
Ph.D.
Degree Date
2010
English Abstract
Oral route of drug administration is the most appealing route for the delivery of drugs.
Of the various dosage forms administered orally, the tablet is one of the most preferred dosage forms because of its ease of manufacturing, convenience in administration, accurate dosing, stability compared with oral liquids, and because it is more tamperproof than capsules.
Pharmaceutical research has been conducted to develop new dosage forms and more stress is laid down on the development of organoleptically elegant and patient friendly drug delivery system for pediatric and geriatric patients.
The proportion of society composed of elderly individuals has risen, indicative of increased longevity.
Hence, it is of increasing importance to address the medicinal needs of this segment of the population in terms of conventional dosage forms.
In this regard, to improve the quality of life and treatment compliance of such patients, a fast dissolving oral dosage in the form of rapidly disintegrating tablets (ODT) appears to be a suitable alternative for oral medication, accounting for difficulties associated with swallowing often encountered by this segment of the population.
The aim of this study was to produce a fast-disintegrating system, which has sufficient hardness for handling and can be manufactured by commonly used production methods and equipment.
The novel, fast-disintegrating system was applied to an actual drug (model drug) to verify its practical use to formulate an effective, safe, non-toxic, non–expensive palatable and stable salbutamol and prednisolone for oral administration as orally disintegrating tablets.
This is a pharmaceutical technology study that investigated basic concepts and main technical challenges in formulation and development of oral disintegrating tablets, and illustrated approaches for using design of experiment and statistical analysis to develop and evaluate a disintegration apparatus to test this novel pharmaceutical formulation.
Pharmaceutical processing technologies followed at various stages during ODT manufacture and clinical study on the prepared model drugs (salbutamol and prednisolone) were extensively carried out.
The basic approach used in the development of the fast-dissolving tablet is the use of superdisintegrants.
The task of developing rapidly disintegrating tablets is accomplished by using suitable diluents and superdisintegrants.
The investigated superdisintegrants were crosspovidone, Ac-d-sol, Primogel and the commercially available coprocessed Pharmaburst.
Evaluation of superdisintegrants included physical properties, disintegrating efficiency, wetting time and water absorption ratio, as well as the factors that affect disintegration process (porosity, temperature, and pH of the disintegrating medium).
Like diluents, each superdisintegrant has strengths and weaknesses; therefore in the present study, the preparation and evaluation of coprocessed disintegrants containing crospovidone and sodium starch glycolate, MCC and sodium starch glycolate, co-ground mixture of crosspovidone and mannitol, was explored Pharmaceutical processing techniques, included milling of co-processed ingredients, the sublimation technology which was applied to produce rapidly disintegrating tablets containing camphor and ammonium carbonate, sieving and particle size determination, in addition to tablet preparation steps.
Solvent evaporation technology was investigated for formulation of taste-masked prednisolone ODT.
The assessed physicochemical characters of the formulated salbutamol and prednisolone included tablet hardness, tablet friability, wetting time, disintegration time and dissolution rate of drug from the ODT.
In addition, taste evaluations of both optimized taste-masked prednisolone and salbutamol ODT were carried out.
The obtained results were subjected to an appropriate statistical analysis design (ANOVA) full factorial design, and the calculated results were compared with the results observed on continuing search for an optimum formulae of the model drugs (salbutamol and prednisolone).
The efficacy and tolerability of the optimized salbutamol ODTs was investigated following a single-blind placebo as a design of clinical trial.
The responses showed by twelve patients diagnosed for moderate asthma were statistically analyzed.
Optimized salbutamol ODT proved equally effective to commercially available salbutamol tablets.
Characterization of the prednisolone ODTs showed by twelve volunteers confirmed that adequate taste masking and faster disintegration could be achieved for prednisolone.
Main Subjects
Topics
No. of Pages
239
Table of Contents
Table of contents.
Abstract.
Chapter One : Introduction.
Chapter Two : Literature review.
Chapter Three : Experimental.
Chapter Four : Results.
Chapter Five : Discussion.
Summary and Conclusions.
References.
American Psychological Association (APA)
Ahmad, Ismail Muhammad Mahmud. (2010). Formulation and in vitro-in vivo evaluation of rapidly disintegrating tablets of salbutamol and prednisolone. (Doctoral dissertations Theses and Dissertations Master). Omdurman Islamic University, Sudan
https://search.emarefa.net/detail/BIM-393277
Modern Language Association (MLA)
Ahmad, Ismail Muhammad Mahmud. Formulation and in vitro-in vivo evaluation of rapidly disintegrating tablets of salbutamol and prednisolone. (Doctoral dissertations Theses and Dissertations Master). Omdurman Islamic University. (2010).
https://search.emarefa.net/detail/BIM-393277
American Medical Association (AMA)
Ahmad, Ismail Muhammad Mahmud. (2010). Formulation and in vitro-in vivo evaluation of rapidly disintegrating tablets of salbutamol and prednisolone. (Doctoral dissertations Theses and Dissertations Master). Omdurman Islamic University, Sudan
https://search.emarefa.net/detail/BIM-393277
Language
English
Data Type
Arab Theses
Record ID
BIM-393277
