Thumb arthritis treatment with diclofenac sodium Gel Formulation
C. Kumaresan
M. Pharm, Ph. D, Chennai, India.
*Corresponding Author E-mail: kumaresan06051979@gmail.com
ABSTRACT:
The diclofenac gel is prepared to treat thumb arthritis pain management. Thumb arthritis pain caused because of more friction in the base of thumb joint. The gel is semisolid dosage forms. The prepared gel is used on the skin, topical use. The affected area is applied over the diclofenac. The two gelling agent xanthan gum and cooling agent menthol were used in the development of the diclofenac sodium gel. The prepared gel formulations were estimated for drug content uniformity, viscosity, pH and stability. The drug release was quantified by in vitro diffusion through a cellulose membrane into phosphate buffer pH 6.8 at 37ºC.
KEYWORDS: Thumb arthritis, diclofenac, drug content, viscosity, In vitro diffusion.
1. INTRODUCTION:
The 8-12 percent of population affected by thumb arthritis. Thumb arthritis leads to hand arthritis. Non-steroidal anti-inflammatory medications such as ibuprofen, diclofenac, acetaminophen are useful (2). The topical gel is significant dosage forms in drug delivery system in the treatment of transdermal drug delivery. The basal layer of epidermis get permeated in topical dosage forms such as gel and cream. The gel formulation gives good patient compliance (3-4).
2. MATERIAL AND METHODS:
Materials:
Diclofenac sodium was obtained from Fourrts India Laboratories, Chennai, India. Xanthan gum was obtained as generous gift samples from Madras Pharmaceuticals, Chennai, India. Other materials used in the study (propylene glycol, methanol, ethanol, potassium dihydrogen phosphate, etc.) were of analytical grade and procured from SD Fine Chemicals, India. Purified water was used throughout the study.
Formulation preparation:
The composition of different gel formulations of code A1, A2, A3 and A4 were shown in Table 1 and evaluated physical chemical measurements (5-6).
Xanthan gum gels:
The xanthan gum was dispersed in purified water to make viscous solution, the diclofenac sodium dissolved in water and dissolved in menthol, propylene glycol and ethanol and mixed with xanthan gum solution with continuous stirring at 37ºC until the gel was formed (1 h 30 mints).
Drug Content:
The Ultra violet spectroscopy used to evaluate diclofenac content in the gel formulation 50% w/w. The phosphate buffer pH 6.8 is used as bulk, the 1gm equivalent diclofenac gel taken from the formulation. The suitable dilution with the bulk solution cum purified water estimated drug content of diclofenac after the filtration through 0.45micron filter. The estimation repeated three times. The λmax used for UV estimation is 276 nm. The diclofenac content in percentage given in Table 2.
Viscosity measurements:
A Brookfield Digital Viscometer was used to measure the viscosity (in cps) of the formulations. The spindle was rotated at 10 rpm. Samples of the gels were allowed to settle over 30 minutes with the temperature (25 ± 1°C) before the estimation. The experiment repeated three times.
pH measurement:
All gel formulations showed a pH range of 6.4-6.9.
Stability studies:
The samples kept in empty tubes, and kept in the temperature 40ºC and 65% relative humidity for 1 month, 2 months, and 3 months. There is no physical change during analysis and homogeneity was observed in all formulations. The pH found the same during preparation and to the entire time period of the analysis.
In vitro diffusion studies:
The modified kesary chien diffusion cell apparatus used to find the in vitro drug (diclofenac) release from the gel formulation. The diclofenac 80mg equivalent gel formulation used for the analysis. The drug release of all the formulation found in the range of 92-98% in 2 hours.
Table 1. Composition of gel formulations (% w/w)
S. No |
Materials |
Code |
|||
A1 |
A2 |
A3 |
A4 |
||
1 |
Diclofenac Sodium |
2 |
2 |
2 |
2 |
2 |
Acetone |
10 |
10 |
10 |
10 |
3 |
Xanthan gum |
1 |
2 |
3 |
4 |
4 |
Propylene glycol |
5 |
5 |
5 |
5 |
5 |
Menthol |
1 |
1 |
1 |
1 |
6 |
Ethanol |
20 |
20 |
20 |
20 |
7 |
Purified water Q.S to make |
50 |
50 |
50 |
50 |
Table 2. Diclofenac Content (% w/w)
S. No |
Materials |
Diclofenac (%) |
||
1 |
2 |
3 |
||
1 |
A1 |
94.9 |
95.2 |
95.2 |
2 |
A2 |
94.6 |
96.1 |
96.0 |
3 |
A3 |
95.8 |
97.1 |
97.2 |
4 |
A4 |
96.7 |
98.1 |
98.4 |
Table 2. Diclofenac Viscosity
S. No |
Materials |
Viscosity η (cps × 103 )a |
||
1 |
2 |
3 |
||
1 |
A1 |
101 |
98 |
102 |
2 |
A2 |
102 |
104 |
104 |
3 |
A3 |
103 |
105 |
106 |
4 |
A4 |
108 |
109 |
110 |
aMean ± SD; n = 3
3. CONCLUSION:
Peoples used to refer horoscope to treat patients is wrong, browsing online horoscope, and online medicines in wrong manner not giving good output. The right physician is essential for every patient. Therefore, peoples take medicines with authorized physician. The prepared formulation is efficient to treat thumb arthritis. The gel formulation viscosity produces smooth penetration through the skin and release a drug in the thumb joint. Further clinical studies in future produces the best use gel formulation to treat thumb arthritis and hand arthritis.
4. ACKNOWLEDGEMENT:
I express my gratitude to Dr. K. Sathishkumar, Dr.R. Parthiban, and Dr. S. Salivahanan, Department of chemical engineering, SSN college of engineering, Kalavakkam, Chennai, Tamilnadu, India.I express my sincere thanks to Shasun Pharmaceuticals, Periyakalapet, Puducherry and Pharma R&D, Biological Evans Ltd, Azamabad, Hyderabad. I express my honour Dr.K.S. Lakshmi, Dr.K. Ilango, Dr.V. Chitra, Dr.N. Damodharan, and Dr.S. Abimanyu, SRM College of Pharmacy, SRM Institute of Science and Technology. I express my thanks and honour to Dr.R. Sundhararajan, Dr. C. Ronald Darwin, Mohamed Sathak A J College of Pharmacy. I express my sincere thanks to Dr. Arivudai Nambi, Novel Laboratories, Mr. Senthil Manickam, Granules india, and Mr. Sasidar Lingala, Shasun Pharmaceuticals.
5. REFERENCES:
1. https://newsnetwork.mayoclinic.org/discussion/mayo-clinic-q-and-a-treating-thumb-arthritis/, assessed on 12/01/2020, 10.00AM.
2. https://www.webmd.com/drugs/2/drug-22221-4289/diclofenac-sodium-topical/diclofenac-3-topical/details, assessed on 12/01/2020, 12.00AM.
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5. Preparation and evaluation of diltiazem hydrochloride diffusion-controlled transdermal delivery system, Limpongsa E, Umprayn K. AAPS PharmSciTech., 2008;9(2):464-70.
6. Formulation and Characterization of Ketoprofen Emulgels, Ramakanth Ambala, Sateesh Kumar Vemula, Journal of Applied Pharmaceutical Science, 2015; 5(7):112-117.
Received on 21.01.2020 Modified on 03.03.2020
Accepted on 11.04.2020 ©Asian Pharma Press All Right Reserved
Asian J. Res. Pharm. Sci. 2020; 10(4):239-240.
DOI: 10.5958/2231-5659.2020.00043.0