Formulation and Evaluation of Oral Dispersion Tablet of Telmisartan
Mahesh PG1*, Raman S.G. 2
1Department of Pharmaceutics, School of Pharmaceutical Sciences, Vels Institute of Science Technology and Advanced Studies, Pallavaram, Chennai 600117.
2Department of Chemistry, School of Pharmacy, Sri Balaji Vidyapeeth Deemed to be University,
Puducherry, India
*Corresponding Author E-mail: pgmahesh83@gmail.com
ABSTRACT:
Aim: Telmisartan is used for treatment of a number of infections including infection of joints and bones, gastroenteritis, malignant obits external, respiratory tract infections, cellulites, urinary tract infections, anthrax, skin structural infections, typhoid fever and it also used in treatment of community acquired pneumonia, chronic bacterial prostitis, nosocomial pneumonia etc. Objective: Difficulty in swallowing (dysphasia) is a common problem of all age groups, especially the elderly and pediatrics, because of physiological changes associated with these groups. Conclusion: In the present work it has been observed from all formulations of Pre compression and post compression studies were given within the limit of values. The in vitro dissolution data, F1 (combination of different super disintegrates) formulation was found that the drug release is best and the cumulative % of drug release was 90.88 % respectively, when compared to other formulation.
KEYWORDS: Gastroenteritis, malignant obits external, dysphasia.
INTRODUCTION:
EXPERIMENTAL METHODS:
PRE-FORMULATION STUDIES:
Pharmaceutical methods substances.
STANDARD CURVE OFTELMISARTAN:
Sodium hydroxide solution, 0.2M:
8gm of sodium hydroxide was dissolved in 1000ml distilled water and it gives 0.2M solution55.
STANDARD CURVE OF TELMISARTAN:
Table No.1: Standard curve of Telmisartan in Phosphate buffer (pH 6.8)
|
S. No |
Concentration (μg /ml) |
Absorbance (290nm) |
|
1 |
0 |
0.00 |
|
2 |
2 |
0.234 |
|
3 |
4 |
0.462 |
|
4 |
6 |
0.686 |
|
5 |
8 |
0.929 |
|
6 |
10 |
1.124 |
Figure No.1: Standard curve of Telmisartan in Phosphate buffer (pH 6.8)
METHOD OF PREPARATION:
Preparation of Telmisartan tablets:
Direct compression technique:
Each tablet weight=200mg
PRECOMPRESSION STUDIES OF POWDER BLENDS:
Angle of repose
θ = Tan-1 (h/r)
Where,
θ = Angle of repose,
h = Height of the powder cone,
r = Radius of the powder cone.
Table No.2: Different Formulation of Telmisartan Oral Dispersible Tablets
|
S. No |
Formulation Code |
Drug |
SSG |
CCS |
Mannitol |
Sodium Saccharin |
Magnesium Stearate |
Mint flavor |
|
1 |
F1 |
10 |
5 |
- |
78 |
5 |
2 |
q. s |
|
2 |
F2 |
10 |
10 |
- |
73 |
5 |
2 |
q. s |
|
3 |
F3 |
10 |
- |
5 |
78 |
5 |
2 |
q. s |
|
4 |
F4 |
10 |
- |
10 |
73 |
5 |
2 |
q. s |
|
5 |
F5 |
10 |
5 |
5 |
73 |
5 |
2 |
q. s |
RESULTS AND DISCUSSION:
PRE-FORMULATION STUDIES:
The present study was undertaken to formulate Telmisartan oral dispersible tablets with three polymers namely., CCS and SSG and in combination of three Super disintegrants and by dry granulation technique.
Table no:3 Pre compression studies of powder blend
|
S. No |
Formulations |
Hardness Test (kg/cm) |
Thickness Test (cm) |
Friability Test (%) |
% of Weight variation test |
Estimation of Drug Content |
|
1 |
F1 |
2.34 |
0.35 |
0.185 |
99.4 |
98.25 |
|
2 |
F2 |
2.35 |
0.35 |
0.206 |
99.5 |
96.39 |
|
3 |
F3 |
3.24 |
0.35 |
0.234 |
99.5 |
96.64 |
|
4 |
F4 |
2.54 |
0.35 |
0.264 |
99.6 |
97.57 |
|
5 |
F5 |
2.25 |
0.35 |
0.234 |
99.7 |
95.75 |
Table no: 4 post compression studies of Telmisartan oral dispersion tablet
|
S. No |
Formulations |
Bulk Density (gm/cm3) |
Tapped Density (gm/cm3) |
Angle of Repose (θ) |
Carr's Index (%) |
Hausner's Ratio |
|
1 |
F1 |
0.382 |
0.375 |
31.34 |
10.16 |
1.329 |
|
2 |
F2 |
0.355 |
0.365 |
35.21 |
6.34 |
1.176 |
|
3 |
F3 |
0.352 |
0.369 |
32.91 |
9.25 |
1.203 |
|
4 |
F4 |
0.386 |
0.319 |
32.40 |
6.19 |
1.165 |
|
5 |
F5 |
0.339 |
0.361 |
34.09 |
9.25 |
1.003 |
Table No.5: Disintergration studies of Telmisartan oral dispersible Tablets
|
S. No |
Formulations |
Disintegration time (sec) |
Wetting time (sec) |
|
1 |
F1 |
19 |
18 |
|
2 |
F2 |
20 |
16 |
|
3 |
F3 |
25 |
18 |
|
4 |
F4 |
23 |
17 |
|
5 |
F5 |
25 |
16 |
Figure No.2: FTIR spectrum of Telmisartan
Figure No.3: FTIR spectrum of SSG
INVITRO DRUG RELEASE STUDY:
Tablets of all the formulations were subjected for invitro release studies. The results are presented in Table no. (5).
Fig no:4 formulation-1(F1)
DISCUSSION:
Oral dispersible tablets of Telmisartan were prepared by direct compression method. The prepared Oral dispersible tablets are round in shape. Microscopic examination of tablets from each formulation batch showed circular result.
CONCLUSION:
In the present work it has been observed from all formulations of Pre compression and post compression studies were given within the limit of values. The in vitro dissolution data, F1 (combination of different super disintegrants) when compared to other formulation.
REFERENCE:
1. Bhowmik. D, Jayakar. B, Kumar. KS. Design and characterization of fast dissolving tablet of telmisartan. International Journal of Pharma Recent Research. 2009;1(1):31- 40.
2. Kalpesh Alai, Thakare VM, Tekade Patil VR. Formulation and evaluation of mouth dissolving tablet by using sublimation technique. World Journal of Pharmaceutical Research. 2012;1(3):838-849.
3. Karemore MN, Soor GP, Shyamala Bhaskaran. Formulation and evaluation of fast dissolving tablet of antihypertensive drug. International Journal of Pharmacy and Technology. 2012; 4(1): 4000-4010.
4. Lokesh. PNV, Abdul Althaf S, Sailaja PB. Design, Development and Formulation of Orodispersible Tablets of a Model Drug Using Response Surface Methodology. Pharmaceutica Analytica Acta. 2012; 3(9):1-15.
5. Mohsin AA, Nimbalakr NE, Sanaullah S, Aejaz A. Formulation and evaluation of mouth dissolving tablets of Amitriptyline Hydrochloride by direct compression technique. International Journal of Pharmaceutics and Pharmaceutical Sciences. 2010; 2(1): 204-210.
6. Rasenack N, Müller BW. Dissolution rate enhancement by in-situ-micronization of poorly water-soluble drugs using a controlled crystallization process. Pharmaceutical Research. 2002; 19(1): 1896-1902.
7. Sammour A, Hammad MA, Megrab NA, Zidan AS. Formulation and Optimization of Mouth Dissolve Tablets Containing Rofecoxib Solid Dispersion. American Association of Pharmaceutical Scientists. 2006; 7(2):1-9.
8. Sekhar V, Chellan VR. Immediate release Tablets of Telmisartan Using Superdisintegrants - Formulation, Evaluation and Stability Studies. Journal of Chemical and Pharmaceutical Bulletin. 2008; 56(2):575-577.
Received on 21.09.2019 Modified on 27.10.2019
Accepted on 23.11.2019 © RJPT All right reserved
Research J. Pharm. and Tech. 2020; 13(7): 3184-3186.
DOI: 10.5958/0974-360X.2020.00563.6