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International Journal of Research in Pharmaceutical and Biomedical Sciences
ISSN: 2229-3701
________________________________________________________________________Research Paper
Formulation and Evaluation of Salbutamol Sulphate
Fast Dissolving Tablet
S. Dineshmohan*, K. Vanitha, A. Ramesh, G. Srikanth and S. Akila
Department of Pharmaceutics, Sitha Institute of Pharmaceutical Sciences, Bachupally, Hyderabad. A. P., India
____________________________________________________________________________________________________ ABSTRACT
Fast dissolving tablets are highly accepted fast growing drug delivery system. This study was aimed at formulation and development of salbutamol sulphate fast dissolving tablet which can dissolve rapidly in the
oral cavity. Asthma is an inflammatory disorder that results in the destruction of air pathways and causes
difficulty in breathing. However other route of drug delivery systems such as aerosols and paranterals have
rapid onset of action but strongly affect the patience compliance. Thus, an attempt was made to improve the
onset of action of bronchodilator used commonly in the treatment of asthma. The tablets were prepared by
direct compression method using superdisintegrants such as Primojel, KollidonCL, L-Hydroxy propyl cellulose.
The prepared tablets were evaluated for weight variation, thickness, friability, hardness, drug content, in vitro
disintegration and in vitro drug release.

Key Words:
Superdisintegrants, salbutamol sulphate, direct compression, fast dissolving tablets

INTRODUCTION

Many patients express difficulty in swallowing administration still continue to be the most preferred tablets and hard gelatin capsules, resulting in non- route because of its patients compliance. Fast compliance and ineffective therapy[1]. Recent dissolving tablets offer an advantage for populations advances in novel drug delivery systems (NDDS) who have difficulty in swallowing its common aim to enhance safety and efficacy of drug molecules among all the age groups and more specific with the by formulating a convenient dosage form for paediatric, geriatric and bedridden patients, and administration and to achieve better patient patients with nausea, vomiting complications. Fast compliance. One such approach led to development dissolving tablets with good taste, flavour increase of fast dissolving tablets[2-4]. Advantages of this drug the acceptability of bitter tasting drugs. Salbutamol delivery system include administration without sulphate is a β2 receptor agonist widely used as water, convenience of administration and accurate bronchodilator to relieve acute asthma. A fast dosing as compare to liquids, easy portability, ability dissolving tablet form would thus be advantageous, to provide advantages of liquid medication in the as salbutamol sulphate is water-soluble and its form of solid preparation, ideal for paediatric and preparation into a fast dissolving form would render geriatric patients. Asthma is a chronic inflammatory it to dissolve rapidly and thereby result in rapid disease, which includes bronchial hyperactivity and absorption without any lag time. Hence an attempt was made for preparation of mouth dissolving tablet responsiveness of tracheo-brochial smooth muscle to of salbutamol sulphate with an aim of reducing the variety of Stimuli, resulting in narrowing of air tubes lag time and providing faster onset of action to often accompanied by increased secretions and relieve the acute asthmatic effect immediately [5]. mucosal edema resulting in breathlessness or dyspnoea, wheezing cough, chest congestion and MATERIALS AND METHODS
anxiety about being unable to breathe .Asthma affects over 5-10% of population in industrialized countries. Salbutamol sulphate was received as a gift It afflicts approximately 53 million people across sample from Star tech pharma (Bangalore, India) world mostly in United States, France, Germany, primojel, L-Hydroxy propyl cellulose, Kollidon CL, Italy, Spain, United Kingdom, and Japan. More than were obtained from Global remedies Hosur,India. 4000 people die every year in India as result of Micro crystalline cellulose and Mannitol -D were complications arising from serious asthma attacks obtained from Everest pharma Hyderabad, India. All though there are several recommendations and other reagents used were analytical grade. ____________________________
*Address for correspondence:
E-mail: akinesh@yahoo.co.in
Vol. 1 (2) Oct – Dec 2010 www.ijrpbsonline.com 105
International Journal of Research in Pharmaceutical and Biomedical Sciences
ISSN: 2229-3701
Preparation of Tablets
Compressibility index [7]
The tablets were prepared by direct compression The simplest way for measurement of free flow method using super disintegrants such as Primojel, of powder is compressibility, a indication of the ease and L-Hydroxy propyl cellulose, Kollidon CL in with which a material can be induced to flow is given varying Concentration (2-6%). All the ingredients by compressibility index (I) which is calculated as (Table 1) were passed through sieve no.60 and mixed in geometric progression in a dry and clean motor. The mixed blend of excipients was compressed into Tablets using 6mm flat beveldeged punches in an 8 I = ————————-
Here, Vo is bulk volume and Vt is tapped volume. Evaluation
Angle of repose[7]
Angle of repose was determined using fixed parameters and results were reported in (Table 2) funnel method. The blend was poured through a funnel that can be raised vertically until a maximum Weight variation test [6]
cone height (h) was obtained. Radius of the heap (r) Randomly twenty tablets were selected and was measured and the angle of repose (q) was average weight was determined. Then individual tablets were weighed and was compared with average weight. The comparison variation within the θ= tan -1 (h / r)
USP limits, it passes the weight variation test. Water absorption ratio[10]
Tablet hardness [7]
A piece of tissue paper folded twice was placed Tablet crushing strength or hardness, the force in a small Petri dish containing 6 ml of water. A required to break a tablet in a diametric compression, tablet was put on the paper and the time required for was measured using Monsanto tablet hardness tester. complete wetting was measured. The wetted tablet The test was performed on 10 tablets and the average was then weighed. Water absorption ratio indicated with R, which is calculated by using the below Wetting time [8]
The wetting time of the tablets can be measured R = (Wa- Wb/ Wb) 100
using a simple procedure. Five circular tissue papers Wa = weight of tablet after absorption of water of 10 cm diameter are placed in a Petri dish with a 10 Wb= weight of tablet before absorption of water cm diameter. Ten millimetres of water containing Eosin, a water soluble dye, is added to Petri dish. A Drug content uniformity[11]
tablet is carefully placed on the surface of the tissue Twenty tablets were weighed and taken in mortar paper. The time required for water to reach upper and crushed to make powder. A quantity of powder surface of the tablet is noted as a wetting time weighing equivalent to 4mg of Salbutamol sulphate was taken in 100 ml volumetric flask containing Bulk Density [7]
distilled water. An aliquot of 2 ml sample was Bulk density was determined by pouring the withdrawn and diluted to 10ml and analyzed by UV blend into a Graduated cylinder. The bulk volume spectrophotometer at 276 nm against blank. Then the (V) and weight of the powder (M) was determined. amount of drug present was calculated using standard The bulk density was calculated by using the below Tablet friability[7]
Mass of granules
The friability of sample of tablets ware measured Bulk density = ——————————
using a Roach Friabilitor. This device consists of a Volume of granules
plastic chamber that is set to revolve around 25 rpm
Tapped density[7]

for 4 minutes dropping the tablets at a distance of 6 The measuring cylinder containing a known mass inches with each revolution. Pre weighed sample of of blend was tapped for a fixed time. The minimum 20 tablets was placed in the friabilator and were volume (Vt) occupied in the cylinder and the weight subjected to 100 revolutions. Tablets were dusted (M) of the blend was measured. The tapped density using a soft muslin cloth and reweighed. The was calculated using the following formula, friability (F %) is given by the formula Loss in weight
% Friability = —————— × 100
Weight of the blend
Initial weight
Tapped density = —————————————
Volume occupied in the cylinder (Vt)

Vol. 1 (2) Oct – Dec 2010 www.ijrpbsonline.com 106
International Journal of Research in Pharmaceutical and Biomedical Sciences
ISSN: 2229-3701
Table 1: Formulation of mouth dissolving tablets of salbutamol sulphate
Ingredients
Table 2: Evaluation of the mouth dissolving tablet of salbutamol sulphate
Formulation parameters
Table 3: In vitro dissolution profile of formulation FD1-FD9 and conventional tablet
Time
(min)

Conventional
Dissolution studies [13]
In Vitro dissolution studies for all the prepared tablets and the marketed available tablets was Carried out using USP paddle method at 50 rpm in 650 ml of Sorenson’s buffer solution (pH - 6.2) as dissolution media, maintained at 37 ± 0.5º. 5 ml of sample was withdrawn from the dissolution Medium at the specified regular intervals, filtered through Whattmann Spectrophotometrically at 276 nm and the drug content was determined by from theStandard calibration curve. In vitro drug release profile
RESULT AND DISCUSSION
In-Vitro Disintegration time[12]
The present study was undertaken to formulate The test was carried out on 6 tablets using tablet and evaluate fast dissolving tablet of Salbutamol disintegration tester ED – 20, Electrolab, distilled sulphate by direct compression method comparing water at 37ºC ± 2ºC was used as a disintegration with the conventional tablet. Bulk densities of media and the time in second taken for complete various formulations varied 0.44 to 0.46 g/cm. The Disintegration of the tablet with no palpable mass angle of repose and the compressibility values varied remaining in the apparatus was measured in seconds. from 21° to 22° and 8.62 to12.24%, respectively. Vol. 1 (2) Oct – Dec 2010 www.ijrpbsonline.com 107
International Journal of Research in Pharmaceutical and Biomedical Sciences
ISSN: 2229-3701
From these values, it was evident that these blends dissolving tablet of salbutamol sulphate 4% w/w and had excellent flow properties. Weight variation was kollidon CL as the superdisintegrant is an alternative found within the specification of the USP limits. to and better than the conventional tablet dosage Average weight of 20 tablets of all nine formulations was found in the range of 98.1 to 100.3 mg. Hardness, thickness and friability of all the tablet ACKNOWLEDGEMENTS
formulations were observed in the range of 2.03 to 2.34 kg/cm2 ,2.51 to 2.53 mm and 0.113 to 0.193%, The authors are thankful to Star tech pharma respectively. Wetting time and water absorption ratio (Bangalore, India) and for providing gift sample of was found in the range of 7.76 to 11.22 s and 65.05 Salbutamol sulphate, Global remedies (Hosur, India.) to 80.35%, respectively. Drug content of all the and Everest pharma (Hyderabad, India.) for formulations was found in the range of 98.98 to 99.14%. The in vitro disintegration time was rapid with L- hydroxyl propyl cellulose containing batches REFERENCES
(8.85 to 8.93 s) and delayed with primojel containing Batches (13.10-13.29s). The rapid disintegration may 1. Seager H. Drug delivery products and zydis fast be due to the rapid uptake of water from the medium, dissolving dosage form. J Pharm Pharmacol 1990; swelling and bursting effect. (Table 2) In vitro dissolution studies of various formulations atdifferent 2. Chang RK, Guo X, Burnside BA, Cough RA. Fast time intervals are reported in (Table 3). The dissolving tablets. PharmTech 2000;24:52-58. formulation Kollidon CLShowed the maximum 3. Dobetti L. Fast-melting tablets: Developments and dissolution rate of 99.84% drug release in 10 min. technologies. PharmaTech Suppl 2001;44-50. Primojel containing Tablets released more than 4. Kuchekar BS, Arumugam V. Fast dissolving 93.77% of the drug in 10 min and L-Hydroxy propyl tablets. Indian J Pharm Educ 200;35:150-152. cellulose formulations released more than 95.07% of 5. Sarasija Suresh, Pandit V, Joshi HP. Indian Journal the drug in 10 min. This shows that the effectiveness of Pharmaceutical Sciences 2007;69(3):467-469. of super disintegrants was in the order of Kollidon 6. Popa G, Gafitanu E. Rev. Med Chir Soc Med Nat CL > Primojel > L-Hydroxy propyl cellulose. The comparative reduction in the drug dissolution rate by 7. Marshall K, In; Lachman L, Liberman HA, Kanig L-Hydroxy propyl cellulose was possibly due to the JL. Eds., Theory and practice of industrial lack of binding force during direct compression. Pharmacy, 3rd Edn, Varghese Publishing house, From the overall observations, formulation FD9 containing 6% w/w Kollidon CL was considered to 8. Sreenivas SA, Gadad AP, Patil MB. Formulation be the best formulation, which releases up to 99.84% and Evaluation of Ondasetron hydrochloride of the drug in 10 min. The in vitro drug release directly compressed mouth disintegrating tablets. profile F9 was compared with Conventional tablet, the conventional tablet released only 49.18% of the 9. United State Pharmacopoeia Convention.NF Asian drug in 10 min. whereas the F9 formulation released up to 99.84%. Thus it can be concluded that the fast 10. Bi Y, Sunada H, Yonezawa Y, Danjo K, Otsuka A, dissolving tablet of Salbutamol Sulphate with 6% w/w Kollidon CL as the super disintegrants an Compressed Tablet Rapidly Disintegrating in Oral alternative to and better than the conventional tablet Cavity. Chem Pharm Bull 1996;44:2121-2127. dosage forms, and the rapid dissolving concept in 11. Pharmacopoeia of India, Ministry of Health and case of Salbutamol sulphate could be of a great Family Welfare, Govt. of India, Controller of importance in relieving acute asthmatic attack. 12. Banker GS, Anderson NR. In: Lieberman CONCLUSION
Lachman HA, Lieberman JL Kanig. The Theory and Practice of Industrial Pharmacy. 3rd ed. In the present study it can be concluded from the Mumbai: Varghese Publishing House, 1987:293- characterization of fast dissolving tablets of 13. United State Pharmacopoeia Convention. NF containing kollidon CL is most acceptable. The fast Vol. 1 (2) Oct – Dec 2010 www.ijrpbsonline.com 108

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