FORMULATION AND DEVELOPMENT OF CURCUMIN AND MAG LOADED ENTERIC COATED TABLET IN THE TREATMENT OF IBD

FORMULATION AND DEVELOPMENT OF CURCUMIN AND MAG LOADED ENTERIC COATED TABLET IN THE TREATMENT OF IBD

Shrikant Rajaram Divekar ^* and Vaibhav R. Vaidya

Department of Pharmaceutics, Dr. D. Y. Patil College of Pharmacy, Akurdi, Pune - 411044, Maharashtra, India.

ABSTRACT: The incidence of Inflammatory Bowel Disease (IBD) is now rising in developing countries and increasingly considered an emerging global disease. IBD is a chronic, intermittent disease. Symptoms of IBD varies from person to person and segment of the intestinal tract involved. IBD diagnosis depends on the various test, which requires blood testing, stool testing, endoscopy, biopsies as well as physical examination with patient history study. The most common side effects of antibiotics in the treatment of IBD are killing microflora with bacteria; hence it makes the condition worst rather than curing. Curcumin has many pharmacological such as anti-inflammatory, anti-oxidative stress, and anti-catabolic activity, which play an important role in mitigating in CD and UC in IBD. Monoammonium glycyrrhizinate (MAG) was recog­nized as a compound possessing antimicrobial properties, MAG tested many researchers using the agar diffusion method, which shows significant antibacterial activities against gram-positive (Bacillus subtilis, Staphylococcus aureus) as well as gram-negative bacteria (Escherichia coli, Pseu­domonas aeruginosa), MAG also decrease the permeability of intestine in IBD which inhibit autoimmune attack. This present study focuses on treating the IBD without disturbing the microflora in an effective way. Thus, the formulating enteric coating drug delivery system containing Curcumin and MAG in combination with local action for healing IBD is possible. This facilitates drug release at the disease location, which gives maximum therapeutic effect and treat IBD with more efficiently.

IBD, Curcumin, Monoammonium Glycyrrhizinate, Enteric Coating

INTRODUCTION: The word “enteric” indicates a small intestine; thus, enteric coatings avoid dissolution and release of medication before it reaches the small intestine. Most enteric coatings work by presenting a coated surface that's stable at the extremely acidic pH scale found within the abdomen, however, breaks down quickly at a less acidic (relatively more basic) pH ^1-6.

Inflammatory bowel diseases (IBD) is mainly the chronic inflammation of the intestine Fig. 1. IBD is divided into two main classes, Ulcerative colitis (UC) and Crohn’s disease (CD). Both UC and CD have the same symptoms with the difference in location of intestine Fig. 2. IBD has similar symptoms and leads to GI disorders and inflammation in the digestive system. The actual reason for IBD is still unknown ^7-8.

There is a number of reason and factor which contribute in CD and UC, some such as inappro-priate diet, genetics, medication, inappropriate immune response, geographical location, environmental condition, and many more.

Common Symptoms of CD and UC involve Diarrhea, Abdominal Pain, Rectal Bleeding, Weight Loss.CD and UC mainly develop in youngsters and adults, developing ratio of CD and UC equal in men and women. In CD and UC lots of similarity but in difference in their symptoms ^9-16.

Curcumin has many activities such as anti-inflammatory, anti-oxidative stress, and anti-catabolic activity ¹⁷. Monoammonium glycyrrhizinate was recog­nized as a compound possessing antimicrobial properties, antibacterial activities against gram-positive it also inhibits autoimmune attack of immunity and decreases the permeability of the intestine in IBD ¹⁸. A combination of Curcumin and MAG effective for IBD focuses on treating the IBD without disturbing the microflora in an effective way.

MATERIALS AND METHODS:

Materials: Drugs:

• Curcumin was obtained as a gift sample from Oliviya Organics Pvt. Ltd. Chennai, Tamil Nadu,
• Monoammonium glycyrrhizinate was obtained as a gift sample from Amsar Pvt. Ltd. Indore, Madhya Pradesh,

Chemicals: Lactose, PVP K-30, Magnesium Stearate, Talc, Eudragit L-100, PEG-400.

Solvents: -Ethanol, Isopropyl Alcohol.

Method:

Preformulation Studies: ^{1-4, 17-18} The aim of preformulation studies are follow:

• To check the physiochemical characterization of a new drug.
• To establish compatibility with different excipients.

Description: The sample was evaluated visually for appearance, color, odor.

Formulation Compatibility Study by using IR:

IR Spectrum of Individual Drug: The drug and potassium bromide disk were prepared manually and separately for each drug by press method. Potassium bromide was used as a blank while running spectrum.

Drug-Drug Compatibility Study: The physical mixture of both drugs (Curcumin + MAG)was prepared in 1:1 ratio. The sample was kept at 38 °C for 45 days and was analyzed for any interaction of drugs.

Drug - Excipients Compatibility Study: The physical mixture of both drug (Curcumin + MAG) with excipients was prepared in 1:1 ratio. The sample was kept at 38 °C for 45 days and was analyzed for any interaction of drugs and excipients.

UV-Visible Spectroscopy:

Calibration curve of Curcumin:

Preparation Stock Solution of Curcumin: (Ethanol AR): 10mg pure curcumin was dissolved in 100 ml ethanol to get a 100ug/ml stock solution. Prepare dilutions of 0.5μg/ml, 1μg/ml, 2μg/ml, 3μg/ml, 4μg/ml, and 5μg/ml respectively. Then measured absorbance of prepared dilutions at the respective wavelength.

Preparation Stock Solution of Curcumin: (In 0.1N HCl): 10mg pure curcumin was dissolved in 10 ml ethanol, then volume makeup up to 100 ml with 0.1N HCl, to get a 100ug/ml stock solution. Prepare dilutions of 0.5μg/ml, 1μg/ml, 2μg/ml, 3μg/ml, 4μg/ml, and 5μg/ml respectively. Then measured absorbance of prepared dilutions at the respective wavelength.

Preparation Stock Solution of Curcumin: (In pH 6.8 Phosphate Buffer): 10mg pure curcumin was dissolved in 10 ml ethanol, then volume makeup up to 100 ml with pH 6.8 Phosphate Buffer, to get a 100ug/ml stock solution. Prepare dilutions of 0.5μg/ml, 1μg/ml, 2μg/ml, 3μg/ml, 4μg/ml, and 5μg/ml respectively. Then measured absorbance of prepared dilutions at the respective wavelength.

Preparation Stock Solution of Monoammonium glycyrrhizinate:

Preparation Stock Solution of Monoammonium glycyrrhizinate: (Ethanol AR): 10mg pure MAG was dissolved in 100 ml ethanol to get a 100ug/ml stock solution. Prepared dilutions of 5μg/ml, 10μg/ml, 15μg/ml, 20μg/ml, 25μg/ml, 30μg/ml, 35μg/ml and 40μg/ml respectively. Then measured absorbance of prepared dilutions at the respective wavelength.

Preparation Stock Solution of MAG: (In 0.1N HCl): 10mg pure drug of MAG was dissolved in 10 ml ethanol, then makeup volume up to 100 ml with 0.1N HCl, to get a 100ug/ml stock solution. Prepare dilutions of 5μg/ml, 10μg/ml, 15μg/ml, 20μg/ml, 25μg/ml and 30μg/ml respectively. Then measured absorbance of prepared dilutions at respective wavelength.

Preparation Stock Solution of MAG: (In pH 6.8 Phosphate Buffer): 10mg pure drug of MAG was dissolved in 10 ml ethanol, then volume makeup upto 100 ml with pH 6.8 phosphate buffer, to get a 100ug/ml stock solution. Prepare dilutions of 5μg/ml, 10μg/ml, 15μg/ml, 20μg/ml, 25μg/ml, 30μg/ml 35μg/ml and 40μg/ml respectively. Then measured absorbance of prepared dilutions at the respective wavelength.

Formulation Design:

Formulation of Core Tablet by Different Concentrations of Binder (PVP 0.5% - 5%):

Procedure for Formulation of Core Tablet: ^19-22 Prepare core tablet with different concentrations of binder solution. PVP in the range of 0.5-5%, granules were prepared by the wet granulation method. Tablets prepared by direct compression method with 8mm punch. Each resultant tablet weight was 210mg.

Formulation Design of Core Tablet (F1-F4):

TABLE 1: FORMULATION TABLE OF CORE TABLET WITH DIFFERENT CONC. BINDER SOLUTION

Evaluation of Core Tablet:

1. Thickness and Diameter test.
2. Hardness test.
3. Friability test.
4. Weight variation test.
5. Disintegration Test

Finalization of Core Tablet: Finalization of the Core tablet batch depends on the evaluation of all four (F1-F4) batches. From evaluation parameters that batch fulfill all parameters, this batch selected for the Coating.

Formulation of Finalized Batch of Core Tablet (0.5% PVP): ^22-23 For core tablet granules prepared by wet granulation method in this 0.5% PVP in IPA use as a binder. Tablets prepared by direct compression method with 8mm punch. Each resultant tablet weight was 210mg.

Formulation Table of Core Tablet (F1):

TABLE 2: FORMULATION TABLE OF SELECTED CORE TABLET (0.5% BINDER SOLUTION)

Pre-Compression Evaluation Parameters of Selected (0.5% PVP Binder Solution) Tablet: ^26-28 In Pre-compression evaluation angle of repose, bulk density and tapped density, carr’s index, hausner’s ratio evaluated.

Post-Compression Evaluation Parameters of Selected (0.5% PVP Binder Solution) Tablet: ^28-29 In post-compression evaluation, thickness and diameter test, hardness test, friability test, weight variation test, disintegration test evaluated

Coating of Tablet:

Preparation of Enteric Coating Solution: ³⁰ In enteric coating solution Eudragit L100 is used as enteric-coated polymer, PEG 400 used as a plasticizer, and Ethanol used as a solvent. The enteric coating solution was prepared with constant stirring on a Magnetic stirrer at 400 RPM.

Optimization of Enteric Coating Solution: ³¹

TABLE 3: OPTIMIZING DESIGN VALUES OF EUDRAGIT L100 & PEG 400

Coating of Tablet in Enteric Coating Solution: ^{20-22, 32} For coating of tablet dipping method was used. Coated tablets were dried at 35 °C for 12 h.

TABLE 4: FORMULATION TABLE OF ENTERIC COATED SOLUTION

Evaluation of Enteric Coated Tablet: ^32-35

1. Thickness and Diameter test.
2. Hardness test.
3. Friability test.
4. Weight variation test.
5. Disintegration Test
6. In-vitro drug release studies.
7. Stability Testing

RESULTS: Physical Properties of Drug:

TABLE 5: APPEARANCE OF CURCUMIN AND MONOAMMONIUM GLYCYRRHIZINATE

Formulation Compatibility Study by using IR:

IR Spectra of Curcumin:

FIG. 3: IR SPECTRA OF CURCUMIN

IR Spectra of MAG:

FIG. 4: IR SPECTRA OF MAG

Drug-Drug Compatibility Study: The FTIR analysis shown no changes in the endothermic peak of the drugs Fig. 5. This study indicated there was no drug-drug incompatibility.

FIG. 5: IR SPECTRA OF CURCUMIN & MAG COMBINATION

Drug Excipients Compatibility Study: The FTIR analysis shown no changes in the endothermic peak of drugs and excipients Fig. 6. This study indicated there was no drug-excipients incompatibility.

FIG. 6: IR SPECTRA OF DRUG (CURCUMIN, MAG) AND EXCIPIENT (LACTOSE + PVP K-30)

Drug Excipient Compatibility of Core Tablet: The FTIR analysis shown no changes in endothermic peak of drugs and excipients in core tablet Fig. 7. This study indicated there was no drug-excipients incompatibility in core tablet.

FIG. 7: IR SPECTRA OF CORE TABLET

Drug Excipient of Enteric Coated Tablet: The FTIR analysis shown no changes in endothermic peak of drugs and excipients in coated tablet Fig. 8. This study indicated there was no drug-excipients incompatibility in the coated tablet.

FIG. 8: IR SPECTRA OF ENTERIC COATED TABLET

UV-visible Spectroscopy:

Summary of Validation Parameter:

TABLE 6: SUMMARY OF VALIDATION PARAMETER OF CURCUMIN AND MAG IN ETHANOL

TABLE 7: SUMMARY OF VALIDATION PARAMETER OF CURCUMIN AND MAG IN 0.1N HCl

TABLE 8: SUMMARY OF VALIDATION PARAMETER OF CURCUMIN AND MAG IN pH 6.8 PHOSPHATE BUFFER

Formulation Evaluation:

Evaluation of Core Tablet [Different Concentrations of Binder (PVP 0.5% - 5%)]

Thickness, Diameter, Hardness:

TABLE 9: EVALUATION TABLE OF CORE TABLET CONTAINING DIFFERENT CONC. OF POLYMER

Friability, Weight Variation, Disintegration:

TABLE 10: EVALUATION TABLE OF CORE TABLET CONTAINING DIFFERENT CONC. OF POLYMER

Finalization of Core Tablet Batch for Coating: Selection of the final batch depends on various evaluation parameters e.g. Thickness, Diameter, Hardness, Friability, Weight Variation and Disintegration Time. After evaluation of above parameters, we selected “F1” formulation (which contain 0.5% PVP), which shown ideal property for core tablet.

Pre-Compression Evaluation Parameters of Selected (0.5% PVP Binder Solution) Tablet:

TABLE 11: PRE-COMPRESSION EVALUATION OF SELECTED CORE TABLET

Post-Compression Evaluation Parameters of Selected (0.5% PVP Binder Solution) Tablet:

TABLE 12: POST-COMPRESSION EVALUATION OF SELECTED CORE TABLET

Evaluation of Enteric Coated Tablet:

Thickness, Diameter and Hardness: 

TABLE 13: ENTERIC COATED TABLET EVALUATION (THICKNESS, DIAMETER, HARDNESS)

Friability, Weight Variation:

TABLE 14: ENTERIC COATED TABLET EVALUATION (FRIABILITY, AVG. WT. VARIATION)

Disintegration Time:

TABLE 15: ENTERIC COATED TABLET EVALUATION (DISINTEGRATION OF ENTERIC COATED TABLET)

In-vitro Drug Release Studies of Enteric Coated Tablets:

% Drug Release of Curcumin:

TABLE 16: % DRUG RELEASE OF CURCUMIN FROM DIFFERENT FORMULATION ENTERIC COATED TABLETS

GRAPH 1: % DRUG RELEASE OF CURCUMIN FROM DIFFERENT FORMULATION ENTERIC COATED TABLETS

% Drug Release of MAG:

TABLE 17: % DRUG RELEASE OF MAG FROM DIFFERENT FORMULATION ENTERIC COATED TABLETS

GRAPH 2: %DRUG RELEASE OF MAG FROM DIFFERENT FORMULATION ENTERIC COATED TABLETS

Optimization Data for Drug Dissolution:

Response 1: Curcumin Drug Release after 2 h:

FIG. 9: 3D & 2D PLOT FOR THE EFFECT OF CONCENTRATION OF EUDRAGIT AND PLASTICIZER ON DRUG RELEASE OF CURCUMIN AFTER 2 h

Response 2: Curcumin Drug Release within 5 h:

FIG. 10: 3D & 2D PLOT FOR EFFECT OF CONCENTRATION OF EUDRAGIT AND PLASTICIZER ON DRUG RELEASE OF CURCUMIN WITHIN 5 h

Response 3: MAG Drug Release after 2 h:

FIG. 11: 3D & 2D PLOT FOR EFFECT OF CONCENTRATION OF EUDRAGIT AND PLASTICIZER ON DRUG RELEASE OF MAG AFTER 2 h

Response 4: MAG Drug Release within 5 h:

FIG. 12: 3D & 2D PLOT FOR EFFECT OF CONCENTRATION OF EUDRAGIT AND PLASTICIZER ON DRUG RELEASE OF MAG WITHIN 5 h

Hardness of Tablet:

TABLE 18: HARDNESS OF ENTERIC COATED TABLET WITH A DIFFERENT TIME INTERVAL 

Stability Testing: From the evaluation of all batches of enteric-coated tablets, “F1” formulation was found better results compared to other formulation. So for the stability study of the enteric-coated tablet, “F1” formulation selected and carried out as per ICH guideline for 6 months (30 °C ±2 °C, RH 65% ± 5%).

Dissolution Study: For stability testing, dissolution carried with a selected time interval (1 month, 2 months, 3 months and 6 months) % Drug Release of Curcumin shown in Table 19 & Graph 3, % Drug Release of MAG shown in Table 20 & Graph 4 with a different time interval (1 month, 2 months, 3 month and 6 months).

%Drug Release of Curcumin with a Different Time Interval:

TABLE 19: % DRUG RELEASE OF CURCUMIN FROM ENTERIC COATED TABLET WITH DIFF. TIME INTERVAL

GRAPH 3: %DRUG RELEASE OF CURCUMIN FROM ENTERIC COATED TABLET WITH DIFF. TIME INTERVAL 

% Drug Release of MAG with a Different Time Interval:

TABLE 20: %DRUG RELEASE OF MAG FROM ENTERIC COATED TABLET WITH A DIFFERENT TIME INTERVAL 

GRAPH 4: %DRUG RELEASE OF MAG FROM ENTERIC COATED TABLET WITH A DIFFERENT TIME INTERVAL

Drug Recovery:

TABLE 21: DRUG RATIO RECOVERY FROM ENTERIC COATED TABLET WITH A DIFFERENT TIME INTERVAL

SUMMARY: In Preformulation study identification of Curcumin and MAG was done. Characterization of FTIR peaks shows all functional groups of Curcumin and MAG. FTIR data confirm that there was no chemical interaction of the drugs with the other excipient used in the formulation. Calibration curve of Curcumin and MAG was performed in 0.1N HCl, Phosphate Buffer pH 6.8 which can be used for drug quantification in dissolution analysis.

Formulation of Core tablets prepared by using different concentration of binder solution and finalization based upon evaluation parameter. Finalized selected batch reproduced for coating. Pre-compression evaluation of core tablet involved (bulk density, tap density, carr’s index, hausner's ratio, angle of repose). Post-compression evaluation of core tablet involved (thickness, diameter, hardness, avg. weight variation, friability, disintegration time). Performed enteric coating of a Finalized batch by dipping method with different optimized polymer and plasticizer solution.

Evaluation of enteric coated tablets involved (thickness, diameter, hardness, weight variation, friability, disintegration time, drug release). In optimization of an enteric coated tablets, F1 formulation was found better results compared to other formulation.

Stability study of enteric coated tablet F1 formulation selected and carried out as per ICH guideline for 6 months (30 °C ± 2 °C, RH 65% ± 5%). This study shows F1 formulation was stable. For stability study, hardness, drug release, drug recovery was performed. All parameter shows formulation was stable.

CONCLUSION: The present study of curcumin and Monoammonium glycyrrhizinate enteric-coated drug delivery system avoid drugs release in a gastric fluid, which minimizes curcumin degradation and directly releaseboth drugs in the intestine to treat Ulcerative colitis (UC) and Crohn’s diseases.

The combination of curcumin and MAG would be treating Inflammatory Bowel Disease more effectively due to its drug release directly at the site of action, which gives more benefits in future Inflammatory Bowel Disease management.

Advantages of curcumin and MAG combinational drug therapy doesn’t have any serious side effect after for prolonged use, which is the main important perspective of this therapy make effective than others.

Curcumin and MAG not only effective in IBD management, but they may be proven effective in Hepatitis, Liver Cirrhosis, skin infection, Rheumatic Arthritis, antibacterial, and other many diseases due to its vast pharmacological activity.

ACKNOWLEDGEMENT: I would like to express thanks to the “International Journal of Pharmaceutical Sciences and Research” for supporting us at every point and provide such a huge platform where we can publish our paper. I would also like to express thanks to the Manager of Oliviya Organics Pvt. Ltd. for providing me a gift sample of Curcumin and The Manager of Amsar Pvt. Ltd. for providing me a gift sample of Monoammonium glycyrrhizinate for my research work. I would also like to thanks my project guide Dr. Vaibhav R. Vaidya, for helping me at every point of my project work.

CONFLICTS OF INTEREST: The author reports no conflict of interest.

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    How to cite this article:

    Divekar SR and Vaidya VR: Formulation and development of curcumin and MAG loaded enteric coated tablet in the treatment of IBD. Int J Pharm Sci & Res 2021; 12(2): 1155-67. doi: 10.13040/IJPSR.0975-8232.12(2).1155-67.

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