Development of Enteric-coated Tablets of Sodium 4,4'-(propnadiamido)dibenzoate
https://doi.org/10.33380/2305-2066-2022-11-2-109-117
Abstract
Introduction. Enteric coat have a wide range of functions: from protecting the API from the adverse effects of the acidic environment of the stomach to targeted delivery to certain parts of the intestine in order to increase the effectiveness of the drug. When developing such dosage forms, special attention is paid to the type of film-forming polymer in the coating composition, its solubility and ability to withstand passage through the stomach.
Aim. Development of enteric-coated tablets based on sodium 4,4'-(prpoandiamido)dibenzoate.
Materials and methods. The objects of the study were sodium 4,4'-(propanediamido)dibenzoate 60 mg core tablets and compositions for enteric coatings. The uniformity of distribution of coatings over tablets was determined by the method developed at the Department of Technology of Medicinal Forms of SPCPU on the basis of the Fokker–Planck equation. The dissolution kinetics of enteric-coated tablets was studied using an Erweka DT 626 tablet dissolution tester (ERWEKA GmbH, Germany). The amount of the substance that passed into the dissolution medium was determined using an SF-2000 spectrophotometer (LLC "OKB Spektr", Russia).
Results and discussion. It has been established that all the studied coatings are evenly distributed over the tablets. When studying the kinetics of tablet dissolution, it was found that all coatings are resistant to acidic environments (0.1 M hydrochloric acid solution), however, in a phosphate buffer solution, the highest rate of release of the substance from tablets is achieved using a coating based on a copolymer of methacrylic acid and ethyl acrylate of the type B.
Conclusion. Tablets based on sodium 4,4'-(propanediamido)dibenzoate, enteric-coated AquaPolish® P white 712.06E were developed.
About the Authors
Ju. M. Kotsur
Saint-Petersburg State Chemical-Pharmaceutical University
Russian Federation
Russian Federation
14A, Prof. Popov str., Saint-Petersburg, 197376
E. V. Flisyuk
Saint-Petersburg State Chemical-Pharmaceutical University
Russian Federation
Russian Federation
14A, Prof. Popov str., Saint-Petersburg, 197376
I. A. Narcevich
Saint-Petersburg State Chemical-Pharmaceutical University
Russian Federation
Russian Federation
14A, Prof. Popov str., Saint-Petersburg, 197376
References
1. Mazova N. V., Marchenko A. L., Smehova I. E. Research and Development of the Composition and Technology Receving of Granules of Omeprazol in the Fluid Bed Apparatus. Drug development & registration. 2019;8(2):74–79. (In Russ.) DOI: 10.33380/2305-2066-2019-8-2-74-79.
2. Mohapatra S. K., Sahoo R. N., Mallick S., Mohapatra R. Enteric Dissolution Enhancement of Engineered Gastro Resistant Omeprazole Tablets using Hydroxypropyl Methylcellulose Acetate Succinate. Indian Journal of Pharmaceutical Education and Research. 2021;55(3):677-684. DOI: 10.5530/ijper.55.3.139.
3. Zhang X., Cheng Y., Li X., Tan X., Shi L., Shi X., Xie C., Li J. Efficacy and safety of the Chinese herbal formula Hewei Jiangni recipe for NERD with cold-heat complex syndrome: study protocol for a double-blinded randomized controlled trial. Trials. 2021;22(1):545. DOI: 10.1186/s13063-021-05471-7.
4. Moutaharrik S., Maroni A., Melocchi A., Zema L., Foppoli A., Cerea M., Palugan L., Neut C., Siepmann F., Siepmann J., Gazzaniga A. Oral colon delivery platform based on a novel combination approach: Design concept and preliminary evaluation. Journal of Drug Delivery Science and Technology. 2021;66:102919. DOI: 10.1016/j.jddst.2021.102919.
5. Nandhakumar S., Sugreevudu G., Harikrishnan N. Formulation design and Evaluation of Extended-Release Tablets of Oxybutynin for Effective Management of Overactive Bladder Syndrome. Research Journal of Pharmacy and Technology. 2021;14(12):6558–6564. DOI: 10.52711/0974-360X.2021.01135.
6. Khannal D., Chang R. Y. K., Hick C., Morales S., Chan H.-K. Enteric-coated bacterioohage tablets for oral administration against gastrointestinal infections. International Journal of Pharmaceutics. 2021;609:121206. DOI: 10.1016/j.ijpharm.2021.121206.
7. Kotsur J. M., Ladytko J. M., Narkevich I. A., Flisyuk E. V. Prediction of the composition of prolonged release tablets based on 4,4’-(propandiamido) sodium dibenzoate using the SeDeM method. Drug development & registration. 2021;10(4):54–62. (In Russ.) DOI: 10.33380/2305-2066-2021-10-4(1)-54-62.
8. Flisyuk E. V., Kotsur J. M., Narkevich I. A., Smekhova I. E., Ivkin D. Yu. Development of the "Dissolution" Test Method for Tablets of Sodium 4,4’-(propanediamido)dibenzoate with Sustained Release. Drug development & registration. 2021;10(4):146–154. (In Russ.) DOI: 10.33380/2305-2066-2021-10-4(1)-146-154.
9. Katona M. T., Kakuk M., Szabo R., Tonka-Nagy P., Takacs-Novak K., Borbas E. Towards a Better Understanding of the Post-Gastric Behavior of Enteric-Coated Formulations. Pharmaceutical Research. 2022;39(1):201–211. DOI: 10.1007/s11095-021-03163-0.
10. Yang Q., Yuan F., Chen J., Zhou H., Yang G., Zhu J. Delayed sustained drug release from electrostatic powder coated tablets with ultrafine polymer blend. Powder Technology. 2021;394:496–503. DOI: 10.1016/j.powtec.2021.08.088.
11. Trinada Rao M., Parimala Y., Yamini M., Phanindra C., Srinivasa Rao Y. Formulation and in vitro evaluation of ramelteon tablets for colon drug delivery system by compression coating. International Journal of Applied Pharmaceutics. 2021;13(2):249–253. DOI: 10.22159/ijap.2021v13i2.40396.
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For citations:
Kotsur J.M., Flisyuk E.V., Narcevich I.A. Development of Enteric-coated Tablets of Sodium 4,4'-(propnadiamido)dibenzoate. Drug development & registration. 2022;11(2):109-117. (In Russ.) https://doi.org/10.33380/2305-2066-2022-11-2-109-117
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