Volume 2 • Issue 1 • 1000105
J Chem Eng Process Technol
ISSN: 2157-7048 JCEPT, an open access journal
Research Article Open Access
Nanjwade et al. J Chem Eng Process Technol 2011, 2:1
DOI: 4172/2157-7048.1000105
Research Article Open Access
Development and Characterization Salbutamol Sulphate Mouth
Disintegrating Tablet
Basavaraj K Nanjwade*, Ritesh Udhani, Jatin Popat, Veerendra K Nanjwade and Sachin A Thakare
Department of Pharmaceutics, KLE University’s College of Pharmacy, Belgaum-590010, Karnataka, INDIA
Keywords: Crospovidone XL-10; Intra and extra granular addition;
Asthma; Mouth feel; Wetting time; Water absorption ratio
Abbreviations: L.O.D: Loss On Drying; MCC: Micro Crystalline
Cellulose
Introduction
Convenience of administration and patient compliance are gaining
signifcant importance in the design of dosage forms. Recently more
stress is laid down on the development of organoleptically elegant
and patient friendly drug delivery system for pediatric and geriatric
patients [1,2]. One important innovation in this direction is the
development of fast dissolving/disintegrating oral dosage forms that
dissolve or disintegrate instantly upon contact with recipient’s tongue
or buccal mucosa [3,4]. A tablet which can rapidly disintegrate in saliva
is an attractive dosage form and a patient-oriented pharmaceutical
preparation [5].
Superdisintegrants are added in formulation to increase the
dissolution characteristics thus increasing bioavailability of drug
[6]. Tere are three methods of addition of disintegrant into the
formulation, intragranular (Internal addition), extragranular (External
addition), partly intragranular and extragranular addition [7]. Te time
for disintegration of orally disintegrating tablets is generally considered
to be less than one minute [8,9,10,11] although patients can experience
actual oral disintegration times that typically range from 5-30 sec.
Many companies have developed various types of fast-disintegrating
dosage forms. A freeze-dried porous wafer known as Zydis [12, 13],
a molding tablet known as EMP [13], an efervescent tablet known as
OraSolve [13], and a disintegrant addition [13] have all been developed.
Asthma is a chronic infammatory disease, which afects over
5-10% of population in industrialized countries [14]. It afects approx.
53 million people across world mostly in United States, France,
Germany, Italy, Spain, United Kingdom, and Japan [14,15]. Tus, an
attempt was made for preparation of fast dissolving tablets of a model
bronchodilator, salbutamol sulphate with an aim of reducing lag time
and providing faster onset of action to relieve immediately acute
asthmatic attack.
*Corresponding author: Dr. Basavaraj K. Nanjwade, Department of Pharmaceutics,
KLE University College of Pharmacy, Belgaum-590010, Karnataka, India, Tel:
00919742431000; Fax: 00918312472387; E-mail: bknanjwade@yahoo.co.in
Received December 07, 2010; Accepted March 15, 2011; Published March 19,
2011
Citation: Nanjwade BK, Udhani R, Popat J, Nanjwade VK, Thakare SA (2011)
Development and Characterization Salbutamol Sulphate Mouth Disintegrating
Tablet. J Chem Eng Process Technol 2:105. doi:10.4172/2157-7048.1000105
Copyright: © 2011 Nanjwade BK, et al. This is an open-access article distributed
under the terms of the Creative Commons Attribution License, which permits
unrestricted use, distribution, and reproduction in any medium, provided the
original author and source are credited.
Abstract
An orodispersible dosage form has been developed as a user-friendly formulation that disintegrates in the mouth
immediately. Thus an attempt was made to improve the onset of action of bronchodilator used commonly in the
treatment of asthma. Formulation was optimized for type of disintegrant used and method of formulation. Disintegrants
such as CCS (Croscarmellose Sodium), SSG (Sodium Starch Glycolate), L-HPC (Low-substituted Hydroxy Propyl
Cellulose), and Crospovidone XL-10 were used and tablets were prepared by direct compression method and wet
granulation. Wet granulation formulation were again sub-divided where disintegrant was added intragranularly in one
type and was added both in intra and extra granulation in the other. Mint favor was added to give good mouth feel.
Out of all formulations prepared, the one prepared with Crospovidone XL-10 added both intra and extra granulation
showed least disintegrating time (9 sec) with good fow property. Direct compression blends had poor fow. Tablets
were also evaluated for various physicochemical parameters. All the tablets showed burst release of drug. Hence,
it was concluded that out of all formulations, the one prepared with Crospovidone XL-10 added both intra and extra
granulation was the best formulation as it showed the least disintegration time.
Material and Methods
Salbutamol sulphate was provided as a gif sample by Lincoln
pharmaceuticals, Ahmedabad, Lactose was obtained from Ranbaxy
Fine-Chem. Ltd, Delhi, MCC PH 101 and Magnesium Stearate
were obtained from Loba chemicals Pvt. Ltd., Mumbai, CCS, SSG,
Crospovidone XL-10 and L-HPC were obtained from Microlabs,
Bangalore and Aerosil was obtained from Eonik Degussa, Mumbai. All
other chemicals were of analytical grade.
Equipment used
UV Spectrophotometer: Systronic 2201 UV/Vis double beam
Spectrophotometer.
Tablet Compression Machine: Rimek 10 Station Press, Cadmach
Machinery Co. Pvt. Ltd., Ahmedabad, India.
Dissolution test apparatus: Dissolution test apparatus-TDT-06T,
Electrolab, Mumbai, India.
Roche friabilator: Camp-bell Electronics, Mumbai, India
Hardness tester: Validated dial type, Model: 1101, Shivani Scientifc
Industries Pvt. Ltd., Mumbai.
Sartorious electronic balance: Model CP- 224 S, Labtronic.
Te amount of disintegrant, lactose and MCC PH 101 was
previously optimized and hence kept constant in all the formulations.
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Chemical Engineering & Process Technology
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ISSN: 2157-7048