Formulation of Novel Medicated Jellies for Treatment of Mouth Ulcer

 

Prof. Sushil D. Patil1*, Mukul J. Gupta1*, Kaustubh S. Kote1*, Mr. Rajendran R2

1Department of Pharmaceutical Chemistry, MET's Institute of Pharmacy, Bhujbal Knowledge City,

Adgaon Nashik, Maharashtra, India.

2Green Chem Herbals, Bangalore Savitribai Phule Pune University, Pune, Maharshtra state, India

*Corresponding Author E-mail: sushilpharma@rediffmail.com

 

ABSTRACT:

Present work here is a jelly with appealing colour and flavour but has an active moiety which will cure mouth ulcer. It will work on both ends i.e. not only cure the round sores but also fill up the deficiencies observed during the Mouth ulcer. Mouth ulcer is a common disease in which a person observes various symptoms like painful sores on skin lining in mouth along with swelling and redness. It is a result of deficiency of vitamin B12 or as a symptom of other disease or disorder. The hydro alcoholic extract of coccinia grandis contain lupeol & taraxerone as active ingredients for wound healing & anti-inflammatory activity. So we formulated medicated jellies and evaluated formulated jellies parameter successfully.

 

KEYWORDS: Mouth ulcer, Medicated jelly, Coccinia grandis, Vitamin B12

 

 


INTRODUCTION:

The present work here is a flavoured jelly to heal mouth ulcer/sores The product formulated is claimed to show its mechanism of action by various routes. First of all it will create a soothing layer of jelling agent onto the sore. Secondly the tannin content will precipitate the surface protein of the sore. Thirdly the drug i.e lupeol will help in sore reduction, wound healing as well as reduce inflammation.

 

MATERIAL AND METHOD:

Master Formula:

Table No.1. Ingredient with quantity ratio with Percentage and its role in formulation

Sr. No

Ingredient

Quantity

Role of ingredient

1

Hydro-alcoholic extract of Coccinia grandis fruit

2-4%

Wound healing & anti-inflammatory

2

Pectin

3-4%

Gelling agent

3

Sucrose

50%

Sweetener

4

Citric Acid

0.1%

Jelly stabilizer & ph modifier

5

Ascorbic Acid

25mg per jelly

Vitamin supplement

6

Folic acid

1mg per jelly

Vitamin supplement

7

Methyl paraben

0.18%

Preservative

8

Propyl paraben

0.02%

Preservative

9

Orange Colour & flavour

2%

Colouring & flavouring agent

10

Water

Q.S.

Vehicle

 

Table No.2. List of Ingredient with Manufactured formulation

Sr. No

Ingredient

Manufactured By

1

Hydro-alcoholic extract of Coccinia grandis fruit

Green Chwem Herbal Banglore

2

Pectin

SDFCL

3

Sucrose

SDFCL

4

Citric Acid

Modern Industries Malegaon-Sinnar

5

Ascorbic Acid

Modern Industries Malegaon-Sinnar

6

Methyl paraben

SDFCL

7

Propyl paraben

SDFCL

 

EXPERIMENTAL WORK:

Extraction:

Hydroalcoholic extract of Coccinia grandis linn.

Coccinia grandis dried fruits were charged to extractor along with ethanol and water. It was extracted by heating the mass in a close system by re pumping the extract to the herb bed. This process was repeated.

 

The extract are combined and concentrated under reduced pressure at low temperature. Then it was charged to spray drier unit to dry and separate the in powder form. Further powdered was added in a multimill to a fine mesh size. It was sieved using a sifter to make uniform particle size. The product was mixed with required quantity of maltodextrin in a blender to make a uniform and homogenous lot. Finally the product is heated, sterilized and sieved. [1-3]

 

Formulation of jelly:

Mix polymer powder with 10ml of water was taken in a beaker mixed it with a magnetic stirrer for 20mins at 900C. After proper hydration of polymer was added sucrose syrup drop wise, along with citric acid. Added drug powder, preservative, colour, flavour, vitamins, etc. let the solution cooled at sufficient temperature and then added to jelly moulds. As the jelly was cooled and settled. Then proceed for the evaluation.[2]

 

RESULTS AND DISCUSSION:

Physical Observation:

The prepared jellies were observed visually for clarity, odor, texture and presence of any particles. The texture was evaluated in terms of stickiness and grittiness by mild rubbing the gel between two fingers.[4]

Weight variation and drug content:

The average weight of ten jellies was taken to determine weight variation. The jellies were taken out of the molds in a beaker and weighed individually, pooled and mixed. Then gel equivalent to 100mg of lupeol was taken in 100 mL volumetric flask, dissolved and made up to the volume using ph 6.8 phosphate buffer. A stability indicating analytical method was employed for the determination of drug. The drug content was estimated by UV/Vis spectrophotometer (Shimadzu UV2800) at 255nm after filtering the sample through Whatman filter paper.[2]

 

Determination of pH:

The pH of prepared jellies was measured using a digital pH meter at room temperature (25°C±5°C). For this purpose, 0.5 g of jelly was dispersed in 50 mL of distilled water to make a 1% solution, and the pH was noted. [3]

 

Viscosity:

Viscosity of jellies was measured in triplicate by Brookfield® viscometer using spindle LV4 at the rotation of 3 rpm at room temperature (25°C ± 5°C). The jelly was squeezed out from the polyethylene mold by making a cut of uniform size on the mold and viscosity was measured.[4]

 

Syneresis:

Syneresis is the contraction of the gel upon storage and separation of water from the gel. It is more pronounced in the gels, where lower concentration of gelling agent is employed. All the jellies were observed for signs of syneresis at room temp (25°C±5°C) and 8°C±1°C. The formulations showing signs of syneresis were rejected and not considered for further studies.[2]

 

In vitro dissolution testing:

In vitro dissolution was studied using USP 28 dissolution Apparatus II (Electrolab Dissolution Tester) in 6.8 pH phosphate buffer (900 mL, 37°C±0.5°C) dissolution medium at 50 rpm. 10mL samples were withdrawn at 5, 10, 15, 20, 25, 30, 40, 50 and 60 min using a prefilter. The sample was replaced by an equal volume of Buffer solution to maintain constant volume throughout. The lupeol dissolved was determined using a calibration curve at 255 nm after suitable dilution. The percentage of lupeol released at 30 and 60 min was calculated from the dissolution data.[2-4]

 

Table No.3.Jelly evaluation of parameter and result

Sr. No.

Evaluation Parameter

Inference

1

Colour

Orange

2

Odour

Orange like

3

Taste

Sweet

4

Weight

2.3-2.5 gm

5

Dissolution testing

85 %

6

Content Uniformity

95 %

7

Consistency

Soft

 

Table No.4. Formulation of Jellies UV results

Sr. No

Concentration (ug/ml)

Absorbance

1

10

0.445

2

20

0.509

3

30

0.626

4

40

0.712

5

50

0.824

 

Fig No.1 Jellies formulation Calibration Curve of UV

 

CONCLUSION:

The above mentioned formulation was formulated for treatment of oral mouth ulcer. The product formulated had proper appearance and consistency. It passes all the evaluation parameter as mentioned.

 

ACKNOWLEDGEMENT:

We would like acknowledge our Institute and management of Bhujbal Knowledge City Institute of Pharmacy, Adgaon Nashik.

 

REFERENCE:

1.      G. Deokar, S. Kshirsagar, S. Nagare, P. Deore, S. Ahhirao, Coccinia grandis fruit extract gel for the treatment of mouth ulcer along with associated wound and inflammation, J. Res. Educ.Indian Med 2017;23(1-2):43-58.

2.      P. Katakam et.al Formulation development and evaluation of novel oral jellies of carba mazepine using pectin, guar gum and gellan gum, Asian journal of Pharmaceutics, October-December 2014,.241-249.

3.      Mangesh D Godbole, Debarshi Kar Mahapatra, Priya D Khode Fabrication and Characterization of Edible Jelly Formulation of Stevioside: A Nutraceutical or OTC Aid for the Diabetic Patients Inventi Rapid: Nutraceuticals 2017; 2:1-9.

4.      Salunke, R. Mayee Formulation and Evaluation of Medicated Jelly of Bitter Drugs T. International Journal of Research Article Pharmaceutical Innovations, September ₋ October 2013; 3(5):1-14

 

 

 

 

 

 

 

Received on 21.08.2019            Accepted on 16.10.2019           

© Asian Pharma Press All Right Reserved

Asian J. Pharm. Tech.  2019; 9(4):241-243.

DOI: 10.5958/2231-5713.2019.00039.4