12-04-2014, 12:28 PM
FORMULATION AND EVALUATION OF MOUTH DISSOLVE TABLETS OF SALBUTAMOL
SULPHATE
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ABSTRACT
New era in an era of Novel Drug Delivery System Formulation research is
oriented towards increasing safety and efficacy of existing drug molecule through
novel concepts of drug delivery. Salbutamol sulphate is a selective 2 receptor
agonist widely used as bronchodilator. In the present research work an attempt
has been made to formulate and evaluate mouth dissolving tablets of salbutamol
sulphate. Mouth dissolving tablets of salbutamol sulphate were prepared using
sodium starch glycolate, croscarmellose sodium and cros-povidone as
superdisintegrants by direct compression and sublimation methods. The tablets
prepared were evaluated for various parameters like weight variations, hardness,
friability, in vitro dispersion time, drug-polymer interaction, drug content, water
absorption ratio and wetting time and in vitro drug release. The tablets prepared
by direct compression method possess a weight variation below ±7.5%, hardness
of 2.5 to 4.0 Kg/cm2, percentage friability of 0.51 to 0.84, in vitro dispersion time
of 11 to 63 seconds, IR spectral analysis showed that there was no drug
interaction with formulation additives of the tablet, drug content uniformity was
in between 96.35 to 104.30%, water absorption ratio of 68.00 to 81.88%.
INTRODUCTION
The oral route of administration still continue to be the most preferred
route due to its manifold advantages including ease of ingestion, pain avoidance,
versatility and most importantly patient compliance. The most popular dosage
form being tablets and capsules1. Even few of the drawbacks of these dosage
forms like swallowing1 and some drugs resist comparison in dense compacts,
owing to their amorphous nature or flocculant, low-density characteristics. Drugs
with poor wetting, slow dissolution properties, intermediate to large dosage,
optimum absorption in the gastrointestinal tract or any combination of these
features may be difficult or impossible to formulate and manufacture as a tablet
that will still provide adequate or full drug bioavailability.
TECHNIQUES FOR PREPARING MOUTH DISSOLVING TABLETS:
Freeze Drying: A process in which water is sublimated from the product after
freezing is called freeze drying. Freeze dried forms offer more rapid dissolution
than other available solid products. The lyophilization process imparts glossy
amorphous structure to the bulking agent and sometimes to the drug, thereby
enhancing the dissolution characteristics of the formulation. However, the use of
freeze drying is limited due to high cost of the equipment and processing. Other
major disadvantages of the final dosage forms include lack of physical resistance
in standard blister packs. Scherer RP patented Zydis technology by employing
freeze drying process for the preparation of mouth dissolving tablets on the basis
of patents issued to Gregory et al. Jaccard and Leyder also utilized lypholization
to prepared orodispersible tablets of various drugs.
Shearform Technology:
The shearform technology is based on preparation of
floss that is also known as ‘shearform matrix’, which is produced by subjecting a
feedstock containing a sugar carrier by flash heat processing. In this process, the
sugar is simultaneously subjected to centrifugal force and to a temperature
gradient, which raises the temperature of the mass to create an internal, flow
condition, which permits part of it to move with respect of the mass. The flowing
mass exists through the spinning head that flings the floss. The floss so produced
is amorphous in nature so it is further chopped and recrystallized by various
techniques to provide uniform flow properties and thus facilitate blending. The
recrystalized matrix is then blended with other tablet excipient and an active
ingredient. The resulting mixture is compressed into tablet. The active ingredient
and other excipient can be blended with floss before carrying out recrystallization.
The shearform floss, when blended with the coated or uncoated microspheres is
compressed into Flashdose or EZ chew tablets on standard tableting equipment.