formulation and evaluation of buccal tablets ppt
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Hi i am sagar kumar mohapatra i would like to get details on formulation and evaalution of bucal tablets ppt.

formulation and evalution of bucal tablets ppt
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Abstract
The study aim was concerned with formulation and evaluation of bioadhesive buccal drug delivery of tizanidine hydrochloride tablets, which is extensively metabolized by liver. The tablets were prepared by direct compression using bioadhesive polymers such as hydroxylpropyl methylcellulose K4M, sodium carboxymethyl cellulose alone, and a combination of these two polymers. In order to improve the permeation of drug, different permeation enhancers like beta-cyclodextrin (β-CD), hydroxylpropyl beta-cyclodextrin (HP-β-CD), and sodium deoxycholate (SDC) were added to the formulations. The β-CD and HP-β-CD were taken in 1:1 molar ratio to drug in formulations. Bioadhesion strength, ex vivo residence time, swelling, and in vitro dissolution studies and ex vivo permeation studies were performed. In vitro release of optimized bioadhesive buccal tablet was found to be non-Fickian. SDC was taken in 1%, 2%, and 3% w/w of the total tablet weight. Stability studies in natural saliva indicated that optimized formulation has good stability in human saliva. In vivo mucoadhesive behavior of optimized formulation was performed in five healthy male human volunteers and subjective parameters were evaluated.

Key words: bioadhesive buccal tablets, in vitro evaluation, in vivo mucoadhesive behavior, permeation enhancers, stability studies in natural saliva, tizanidine hydrochloride
INTRODUCTION
Bioadhesive buccal delivery of drugs is one of the alternatives to the oral route of drug administration, particularly to those drugs that undergo first-pass effect. The stratified squamous epithelium supported by a connective tissue lamina propria, which is present in buccal mucosa (1), was targeted as a site for drug delivery several years ago. Problems accompanied with oral route of administration such as extensive metabolism by liver, drug degradation in gastrointestinal tract due to harsh environment, and invasiveness of parenteral administration can be solved by administering the drug through the buccal route (2,3). The buccal route appears to offer a number of advantages, like good accessibility, robustness of the epithelium, usage of the dosage form in accordance with need, and comparatively less susceptibility to enzymatic activity. Hence, adhesive mucosal dosage forms were prepared for oral delivery, in the form of adhesive tablets (4,5), adhesive gels (6,7), and adhesive patches (8).

The permeation of hydrophilic drug through membrane is one of the major limiting factors for the development of bioadhesive buccal delivery devices. The epithelium that lines the buccal mucosa is a main barrier for the absorption of drugs (9). In order to improve buccal absorption, several approaches have been introduced. Increased permeation of the drug through the buccal membrane and prevention of the drug degradation by enzymes was achieved by changing the physicochemical properties of the drug (10). Alternatively, improving the bioadhesion and release characteristics of buccal delivery devices increases the amount of drug available for absorption (11). The incorporation of absorption enhancers to the buccal formulation is one interesting approach. Substances that facilitate the permeation through buccal mucosa are referred as permeation enhancers (12). Different types of potential permeation enhancers have been studied for buccal route to increase the penetration of drugs (13,14).

The complexation of steroidal hormones with cyclodextrins was not effective in increasing the permeation through buccal route, whereas condensation products of cyclodextrin with propylene oxide or epichlorohydrins were able to form complexes with estradiol, testosterone, and progesterone, thereby enhancing absorption through the buccal membrane in humans (15).

The delivery of hydrophilic macromolecular drugs via buccal membrane was made possible by incorporation of absorption or permeation enhancers, which could reduce barrier properties of the buccal epithelium (13–20).

Tizanidine hydrochloride (TZD HCL) is an imidazoline derivative, which acts as agonist on centrally located α2 receptors and this leads to myotonolytic effects on skeletal muscle (21–24). It is structurally and pharmacologically similar to clonidine and other α2-adrenergic agonists (23,24). The correct mechanism of tizanidine in decreasing muscle tone and frequency of spasm is not clearly understood (24).

About 53% to 66% of the dose administered is being absorbed through the gastrointestinal tract after oral administration and the peak plasma concentration is reached within 1 to 2 h. Bioavailability of tizanidine is about 34% to 40% and half-life is 2.5 h. The drug is widely distributed throughout the body and 30% of drug binds to plasma proteins. It undergoes rapid and extensive first-pass metabolism in the liver (approximately 95% of a dose), leading to the oxidation of the imidazoline moiety, aromatic system, and the sulfur atom. This leads to lower bioavailability of tizanidine (25). In order to overcome such extensive first-pass metabolism, the drug is selected as suitable candidate for bioadhesive buccal drug delivery.

The aim of the present study was to develop a new bioadhesive sustained-release tablets for buccal drug delivery of tizanidine hydrochloride.
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