Evaluation of Prepared Aspirin Modified Release Tablets with Polymer Isolated from Fresh Mosambi Leaves
K. Vyshnavi1, Madhuri Bhashetty1, Namitha Swain1, M. Venkataswamy1, Alluri Ramesh2
1Department of Pharmaceutics, Vishnu Institute of Pharmaceutical Education And Research, Vishnupur, Narsapur, Medak, Telangana, India
2Department of Pharmacology, Vishnu Institute of Pharmaceutical Education And Research, Vishnupur, Narsapur, Medak, Telangana, India
*Corresponding Author E-mail: venkataswamy.m@viper.ac.in
ABSTRACT:
The aim1 of present work was to extract and isolate polymer from dried mosambi leaves to as a binding property in tablets using Aspirin as a drug. First we have to collected the fresh leaves of mosambi cleaned it and dried. Then make the dried leaves as a powder and extracted the powder by using soxhlet apparatus. For comparing methyl cellulose polymer was used as a reference. Totally 5 formulations F1, F2, F3, F4, F5 were prepared. After the evaluation of prepared tablets formulation F5 was found to be the best formulation and showing good polymer characteristics than the other formulations.
KEYWORDS: Fresh Mosambi Leaves, Polymer, Evaluation.
INTRODUCTION:
Modified release compound is used to distinguish the changes in time and release rate of the compound. From this concept the compound release characteristics of respective time can be calculated to attain therapeutic activity of the compound. This type of release dosage1-4 forms is far better than the conventional release dosage forms. This is showing more half life and less administration when compare to the conventional release dosage form. In this work we are focusing about the polymer prepared from mosambi leaves extract. Reference compound used to compare the prepared polymer is methyl cellulose. Aspirin is the drug selected in this study to prepare a tablet. Aspirin is an anti-inflammatory drug. This is used for fever, pains…etc.
MATERIALS AND METHODS:
List of Materials:
Aspirin, mosambi leaves isolated mucilage, sucrose, magnesium stearate, talc, Purified water.
Extraction:
collect fresh mosambi leaves and dried it. The Dried mosambi leaves powder (200g) is used. Acidify water using 0.55N citric acid and maintaining pH 2. Heat the mixture in R B flask at 80º C for about 6 to 9 hrs. Powder and solvent ratio will be taken as 1:5, then filter the mixture and cooled it5-7.
Isolation:
Take twice amount of ethanol and added to the above extract and stir it for 20min. Then keep it aside for 2.5hrs, and then filter it. The product obtained was washed 4times by ethanol and keep it for drying at 45-50ºC and stored it.
Preparation of Tablets:
Five different batches of tablets were prepared by using wet granulation technique. The formula used to prepare a single tablet per batch is given in table 1. Calculate the amounts which were required to prepare 400 mg Aspirin tablets, containing 250 mg drug, binder and filler and mixed uniformly. Add sufficient amount of water to prepare wet mass. Granules were prepared by sieving method. Then, dry the granules at 35-45ºC for six hours. Store the granules in desiccators. Punch the tablets by using punching machine8-9.
Table 1: Formula used to prepare tablet.
|
S. No |
Ingredients |
Formulations (gms) |
|||||
|
F1 |
F2F |
F3 |
F4 |
F5 |
REF |
||
|
1 |
Drug (Aspirin) |
0.25 |
0.25 |
0.25 |
0.25 |
0.25 |
0.25 |
|
2 |
Binder (Pectin) |
0.1 |
0.2 |
0.3 |
0.4 |
0.5 |
- |
|
3 |
Sucrose |
0.01 |
0.01 |
0.01 |
0.01 |
0.01 |
0.01 |
|
4 |
Menthol |
0.001 |
0.001 |
0.001 |
0.001 |
0.001 |
0.001 |
|
5 |
Peppermint oil |
0.004 |
0.004 |
0.004 |
0.004 |
0.004 |
0.004 |
|
6 |
Talc (1%) |
q.s |
q.s |
q.s |
q.s |
q.s |
q.s |
|
7 |
Starch (10%) |
q.s |
q.s |
q.s |
q.s |
q.s |
q.s |
|
8 |
Lactose (mg) |
q.s |
q.s |
q.s |
q.s |
q.s |
q.s |
Evaluation of Tablets
Weight variation:
The prepared formulations were evaluated for weight variation studies. 20 tablets of each batch were used to evaluate weight variation among tablets and mean and standard deviation was calculated10.
Friability:
The prepared tablets of all batches were used to evaluate friability test10,11.
Hardness:
Hardness of prepared tablets all batches was determined using Monsanto hardness tester10,11.
Thickness:
The thickness of prepared tablets the matrix tablets was determined using vernier caliper12-14.
Drug Content:
Weigh the powdered tablets 250 mg equivalent weight of Aspirin from tablet and transferred into a 100 ml volumetric flask. Add 10 ml of phosphate buffer (pH 7.4) and shake around 10 min. Then, the make up the volume up to 100 ml with buffer. Then filter the solution in volumetric flask, take 1ml from it and dilute it then analyzed at 265nm using UV- visible spectrophotometer.
In-Vitro Drug Release Study:
The In-vitro drug release studies was carried out using Dissolution Apparatus, in 900 ml phosphate buffer pH 7.4, maintain temperature at 37±1°C for 4 h, at 100 rpm. 5ml of sample was withdrawn after given time intervals, with replacing fresh medium. Then the samples were analyzed spectrophotometrically measured at wavelength of 265nm.
RESULTS:
The prepared tablets were evaluated for post compression parameters such as weight variation, hardness, thickness, drug content uniformity, and in vitro release characteristics. The readings were obtained. Weight variation among all tablets ranged between 0.015 (±0.224) mg to 0.020 (±0.31) mg. Hardness values, which were obtained within limits ranged from 0.1 (±0.01) N to 0.2 (±0.02) N. Similarly, the best drug release in four hours was found to be 21.25% in batch F5, which is far less than the release of drug in reference batch (approximately 50.24%). All these values have been tabulated below in table 2. In-vitro release profile of the drug from the tablets was major role to decide whether the natural polymer (mosambi leaves) or the commercially used binder (methyl cellulose as in reference batch) is good binding agent. The release profile for the drug was taken for a period of four hours which can best be depicted by graph between percentage drug release and time. Batch F5 formulation containing mucilage from mosambi leaves acts as binder shows minimum release of 21.255 % as compared to other batches of same polymer.
Table no. 2 Evaluation of tablets
|
S. No |
Parameters |
Formulations |
|||||
|
F-1 |
F-2 |
F-3 |
F-4 |
F-5 |
Reference |
||
|
1 |
Weight variation |
0.052 |
0.063 |
0.074 |
0.083 |
0.092 |
0.075 |
|
2 |
Hardness (kgs) |
0.33 |
0.41 |
0.52 |
0.62 |
0.73 |
0.51 |
|
3 |
Friability |
9.324 |
8.243 |
5.875 |
12.542 |
15.275 |
5.78 |
|
4 |
Disintegration (min) |
11 |
12 |
14 |
15 |
17 |
12 |
Table no. 3: Dissolution studies:
|
Time (min) |
% DRUG RELEASE |
|||||
|
F1 |
F2 |
F3 |
F4 |
F5 |
REF |
|
|
0 |
0.1485 |
0.3132 |
0.3663 |
0.6075 |
0.2475 |
0.5661 |
|
5 |
0.6138 |
0.8856 |
0.4059 |
0.783 |
0.3366 |
1.3617 |
|
10 |
1.2573 |
1.5768 |
0.9306 |
0.9855 |
0.4851 |
2.0502 |
|
15 |
1.9305 |
2.862 |
1.4454 |
2.2815 |
1.3464 |
3.9321 |
|
20 |
2.3562 |
2.9268 |
1.9602 |
2.3355 |
1.5741 |
4.5594 |
|
25 |
2.4651 |
3.0132 |
2.3562 |
2.511 |
1.6632 |
5.4009 |
|
30 |
3.5343 |
5.7024 |
2.7819 |
4.833 |
1.8513 |
7.6194 |
|
45 |
4.7124 |
7.5708 |
3.6333 |
8.2755 |
2.1384 |
9.5472 |
|
60 |
5.6826 |
15.4116 |
5.1876 |
11.286 |
3.4452 |
19.4769 |
|
120 |
10.3752 |
27.5076 |
12.3255 |
21.222 |
6.5835 |
28.6569 |
|
180 |
16.0974 |
31.6224 |
18.0576 |
31.266 |
15.1173 |
36.2151 |
|
240 |
23.0076 |
37.2816 |
23.2254 |
44.064 |
21.2553 |
50.2452 |
Fig: in-vitro drug release studies
CONCLUSION:
The water based hot percolation extraction is an efficient method for extracting natural polymer from mosambi leaves powder. From the above results it is concluded that the natural polymer extracted from natural plant acts as a good binding agent. It plays a major role to prepare controlled, sustained release formulations and has a great future exposure.
REFERENCES:
1. Pranati Srivastava, Rishabha Malviya, Giriraj T. Kulkarni “Formulation And Evaluation of Paracetamol Tablets To Assess Binding Property of Orange Peel Pectin” International Journal of Pharmaceutical Sciences Review and Research, Volume 3, Issue 1, July –August 2010 ; Article 006
2. Leon Shargel, Susanna Wu-Pong, Andrew B.C. Yu, “Applied biopharmaceutics and pharmacokinetics, 6th edition.
3. Soppimath KS, Kulkarni AR, Aminabhavi TM, Chemically modified polya crylamide -guar gum based cross linked anionic microgels as pH -sensitive drug delivery systems: preparation and characterization, Journal of Controlled Release, 75, 2001, 331 –345.
4. Malviya R, Srivastava P, Bansal M, Sharma PK, Preparation and Evaluation of Disintegrating Properties of Cucurbita Maxima Pulp Powder, International journal of pharmaceutical sciences (accepted manuscript IJPS-09-119, 2010)
5. Derek GP, Braian JP, Water binding properties of hydrogel polymers for reverse osmosis and related applications, British Polymer Journal, 11(3), 2007, 130-136.
6. Thakur BR, Chemistry and uses of pectin-A review, Critical Reviews in Food Science and Nutrition. 37, 1997, 47-73.
7. Joye DD, Luzio GA, Process for selective extraction of pectins from plant material by differential pH, Carbohydrate Polymer, 43(4), 2000, 337-342.
8. Ritger PL, Peppas NA, A simple equation for description of solute release, II: Fickian and anomalous release from swellable devices, Journal of Controlled Release , 5, 1987, 37-42.
9. Sato H, Miya gawa Y, Okabe T, Miyajima M, Sunada H, Dissolution mechanism of diclofenac sodium from wax matrix granules, Journal of Pharmaceutical Sciences, 86, 1997, 929-934
10. The official compendium of standards, The United States Pharmacopoeial Convention, 2007, USP30 -NF25.
11. Ei-Arini SK, Leuenberger H, Modeling of drug release from polymer matrices: Effect of drug loading, International Journal of Pharmaceutics, 121, 1995, 141 -148.
12. Ronald H, Schmidt HK, Molecularly Imprinted Polymer Films with Binding Properties Enhanced by the Reaction -Induced Phase Separation of a Sacrificial Polymeric Porogen, Chemical Materials,17(5), 2005, 1007– 1016.
13. European Pharmacopoeia, fourth ed., Suppl. 4.1, Published by the directorate for the quality of medicines of the council of Europe 9EDQM, Strasbourg, France, 2002.
14. Sherimeier S, Schmidt PC, Fast dispersible ibuprofen tablets. European Journal of Pharmaceutical Sciences, 15, 2002, 295 –305.
Received on 02.04.2017 Modified on 02.05.2017
Accepted on 19.06.2017 ©A&V Publications All right reserved
Res. J. Pharm. Dosage Form. & Tech. 2017; 9(2): 45-47.
DOI: 10.5958/0975-4377.2017.00009.X