Formulation Of Sublingual Tablets Biology Essay

Published:

This essay has been submitted by a student. This is not an example of the work written by our professional essay writers.

The aim of the present study was to develop Sublingual tablets containing Tamsulosin hydrochloride, using various hydrophilic and hydrophobic polymers such as HPMC, Pectin, Polyvinylpyrrolidone (pvp), β-Cyclodextrin, Ethyl cellulose (EC), to know whether which release pattern it follows whether it may give onset of action or prolonged action. In this work Tamsulosin Hydrochloride was selected as an ideal drug candidature to treat Benign Prostatic Hyperplasia & Urinary tract infection manly by blockage of α- 1Asub type adrenoceptor causes relaxation of smooth muscles in the bladder neck and prostate, and thus decreases urinary outflow resistance in men.

FORMULATION OF SUBLINGUAL TABLETS:

In the present study, an attempt was made to prepare different formulations of oromucosal drug delivery system, using various hydrophilic and hydrophobic polymers. There are two methods has been adapted for preparation of sublingual tablets. In the first method, the core tablet was prepared by direct compression of Tamsulosin hydrochloride with ethylcellulose (F1 EC, F2 EC, F3 EC, F4 EC, and F5 EC) and similarly with HPMC, Pectin, Polyvinylpyrrolidone (pvp), β-Cyclodextrin( F1HP, F2 HP, F3 HP, F4 HP, F5 HP, F1 P, F2 P, F3 P, F4 P, F5 P & F1 PVP, F2 PVP, F3 PVP, F4 PVP, F5 PVP & F1 CD, F2 CD, F3 CD, F4 CD, F5 CD) and without using polymers directly with mannitol C1, C2. In second method, bilayered tablets were prepared using tamsulosin hydrochloride, mannitol as core tablet and EC compressed over it as a backing layer (B1, B2). The prepared various tablets were subjected to physicochemical evaluation, incompatability studies, in vitro drug release and finally t-test was performed to the obtained results.

COMPATABILITY STUDIES:

The compatability studies of the drug and the polymer and various formulations were estimated by using FT-IR (Jasco- T-IR 8201 PC). The IR spectrum of the pure drug (Tamsulosin Hydrochloride) showed a intense peaks at 3305.39cm-1, 1159.01cm-1, 2983.34cm-1, 748.245cm-1, 1251.58cm-1 and these were compared with the standard IR spectrum (IP). Similarly the same peaks were observed in all formulations. From the spectra, shown in the fig. , finally there was no significant incompatibility between the pure drug, polymer and in all 34 formulations, indicating the stability of the drug in these formulations.

EVALUATION OF PHYSICOCHEMICAL PARAMETERS:

Thickness

The thickness of all the tablets falls in the range of 2.300±0.108 to 2.369±0.107 for EC containing formulations, 2.359±0.041 to 2.4347±0.037 for pectin containing formulations, 2.3421±0.00 to 2.3814±0.00145 for β- cyclodextrin containing formulation, 2.210±0.003 to 2.2475±0.0029 for pvp containing formulations, 2.3522±0.003 to 2.4161±0.0039 for hpmc containing formulations. For the formulations B1 and B2 thickness was found to be 2.364±0.019, 2.4162±0.001, and for C1 and C2 it was found to be 2.365±0.015, 2.349±0.021.

B. Weight Variation Test

In weight variation test, the Pharmacopoeial limit (United States Pharmacopoeia, 2000) for percentage deviation less than or equal to 150 mg is ±7.5%. The average percentage deviation of all tablet formulations was found to be within the limits, and hence all formulations passed the uniformity of weight as per official requirements of the United States Pharmacopoeia, 2000.

C. Hardness Test

Formulated Tamsulosin Hydrochloride Sublingual tablets were tested for hardness using Pfizer hardness tester. The hardness increased as the concentration of the binder increased. All Formulations showed a maximum hardness of 1 kg/cm2, whose hardness was nearly similar to that of the reference marketed isosorbide Dinitrate sublingual tablet (isordil-5) (1.5 kg/cm2).

D. Friability Test (Banker and Ander, 1987)

Tablet hardness is not a complete indication of strength. An additional measure of a tablet's strength is friability. Conventional compressed tablets that lose less than 1% of their weight are generally considered acceptable. In the present study, the percentage friability for all the formulations were below 1%, indicating that the friability was within the prescribed limits. The results were 0.9472 to 1.47 for EC, 0.476 to 0.924 for Pectin, 0.7304 to 0.874 for β- cyclodextrin, 0.74 to 0.9 for PVP, 0.469 to 0.997 for HPMC containing formulations and for B1 & B2 obtained were 0.261 , 0.177, C1 &C2 0.784, 0.867.

E. Disintegration Test

Disintegration test was carried out for formulated tablets using disintegration test apparatus as prescribed in USP, 2000. All formulations disintegration test were shown to be between 92-177 seconds.

F. DRUG CONTENT UNIFORMITY

Tamsulosin Hydrochloride Sublingual tablets are tested for drug content as prescribed in IP, 2007. Good uniformity in content was found among different formulations and the percentage of drug content was more than 100% and all the batches were in the limit according to the limits mention in the I.P. The Percentages of drug content uniformity present in all the formulations were found to be in between 91.87-108%

G. DRUG CONTENT ASSAY

Tamsulosin Hydrochloride Sublingual tablets are tested for drug content assay as prescribed in IP, 2007. Drug content assay was found among different formulations and all the batches were in the limit according to the limits mention in the I.P. The Percentages of drug content present in all the formulations were found to be 95.43-104%.

H. IN-VITRO DISSOLUTION STUDIES

Figuresshows the dissolution profile of the prepared Tamsulosin Hydrochloride sublingual tablet formulations. In-vitro release profile of the drug from the tablets was major governing criteria using binder and diluents as mannitol. The release profile for the drug was taken to be best for a period of 10min without polymer and whereas 15min was observed with polymer HPMC, Pectin, PVP, β-cyclodextrin at ratio of (1:0.25) and which can best be depicted by graph between percentage drug release and time.

Writing Services

Essay Writing
Service

Find out how the very best essay writing service can help you accomplish more and achieve higher marks today.

Assignment Writing Service

From complicated assignments to tricky tasks, our experts can tackle virtually any question thrown at them.

Dissertation Writing Service

A dissertation (also known as a thesis or research project) is probably the most important piece of work for any student! From full dissertations to individual chapters, we’re on hand to support you.

Coursework Writing Service

Our expert qualified writers can help you get your coursework right first time, every time.

Dissertation Proposal Service

The first step to completing a dissertation is to create a proposal that talks about what you wish to do. Our experts can design suitable methodologies - perfect to help you get started with a dissertation.

Report Writing
Service

Reports for any audience. Perfectly structured, professionally written, and tailored to suit your exact requirements.

Essay Skeleton Answer Service

If you’re just looking for some help to get started on an essay, our outline service provides you with a perfect essay plan.

Marking & Proofreading Service

Not sure if your work is hitting the mark? Struggling to get feedback from your lecturer? Our premium marking service was created just for you - get the feedback you deserve now.

Exam Revision
Service

Exams can be one of the most stressful experiences you’ll ever have! Revision is key, and we’re here to help. With custom created revision notes and exam answers, you’ll never feel underprepared again.