Preparation and Evaluation of Oroslippery Tablets Contain Irbesartan and Hydrochlorothiazide Combination for Dysphagia Patients
DOI:
https://doi.org/10.31351/vol31iss2pp91-100Keywords:
Dysphagia, Hydrochlorothiazide, Irbesartan, Oroslippery tablets (OST), and Slipperiness test, HPLC, ICH guidelineAbstract
Oro slippery tablets (OSTs) is a technique used to improve swallowing of tablets for patients with dysphagia. The aim of this study was to formulate irbesartan and hydrochlorothiazide as Oroslippery tablets (OST) containing 150 mg irbesartan and 25 mg hydrochlorothiazide for dysphagia patients. A simple and rapid method of analysis was developed and validated according to the ICH guideline using HPLC with UV detector. Tablets were prepared by direct compression and then coated with the slippery coat of three different concentrations of the slippering substance “xanthan gum’ (2%, 3% and 4%) in Opadry Colorcone® and evaluated according to USP. Slipperiness test was performed using Albino rabbits. Results showed that 2% xanthan gum gave the shortest swallowing time. Also, disintegration time was increased by the coat significantly with the increase of the gum’s concentration in the coat. The release kinetics study of the tested formulations (uncoated versus coated with 2% gum) gave the highest correlation for the "first-order release model" for both drugs in the absence and presence of the slippering agent which indicates that the coating did not interfere with the release kinetics of both drugs. In a conclusion, 2% xanthan gum as slippering agent the optimum concentration used to promote easy ingestion of this tablet.
References
Khan A, Carmona R, Traube M. Dysphagia in the Elderly. Clin Geriatr Med 2014; 30: 43–53.
Abdel Jalil A A, Katzka D A, & Castell DO. Approach to the patient with dysphagia. Am J Med 2015;128(10): 17-23.
Chang MC, Lee C, Park, D. Validation and Inter-rater Reliability of the Modified Videofluoroscopic Dysphagia Scale in Dysphagic Patients with Multiple Etiologies. J Clin Med. 2021; 10(13): 2077-0383.
Vieira JM, Andrade CC , Santos TT, Okuro PK , Garcia ST, Rodrigues MI, Vicente AA, Cunha RL. Flaxseed gum-biopolymers interactions driving rheological behaviour of oropharyngeal dysphagia-oriented products. Food Hydrocoll 2021; 111 : 106257.
Taylor S, Glass BD. Altering dosage forms for older adults. Australian prescriber 2018; 41(6): 191–193.
Perrie Y, Badhan RK, Kirby DJ, Lowry D, Mohammed AR, Ouyang D. The impact of ageing on the barriers to drug delivery. J Control Release. 2012;161(2):389-398.
Mc Gillicuddy A, Crean AM, Sahm LJ. Older adults with difficulty swallowing oral medicines: a systematic review of the literature. Eur J Clin Pharmacol 2016;72(2):141-151.
Mc Gillicuddy A, Crean AM, Sahm LJ. Older adults with difficulty swallowing oral medicines: a systematic review of the literature. Eur J Clin Pharmacol. 2016;72(2):141-151.
Mahdi Z H, Maraie N K. New Easily Swallowed Tablets with Slippery Coating for the Antihypertensive Drug Valsartan. UK J Pharm Biosci 2015; 3(5): 9.
Almajidi YQ, Maraie NK. An overview on oroslippery technique as a promising alternative for tablets used in Dysphagia. Res J Pharm Technol 2019;12(9): 4545–4549.
Haldar R N Global Brief on Hypertension: Silent Killer, Global Public Health Crisis. Indian J phys med Rehab 2013;24(1): 2–2.
Williams B, Mancia G, Spiering W, Agabiti RE, Azizi MB, Clement DL, Coca A, de Simone G, Dominiczak A., et al. ESC/ESH Guidelines for the management of arterial hypertension: The Task Force for the Management Of Arterial Hypertension of the European Society of Cardiology and the European Society of Hypertension. J Hypert 2018; 36:1953–2041.
Burnier M, Forni V, Wuerzner G, et al. Long-term use and tolerability of irbesartan for control of hypertension. Integr Blood Press Control 2011; 4: 17–26.
National Center for Biotechnology Information (2021). PubChem Compound Summary for CID 3749, Irbesartan. Retrieved November 4, 2021 from https://pubchem.ncbi.nlm.nih.gov/compound/Irbesartan
Derosa G, Ferrari I, Cicero AFG. Irbesartan and hydrochlorothiazide association in the treatment of hypertension. Curr Vasc Pharmacol 2009; 7: 120–136.
https://database.ich.org/sites/default/files/Q2%28R1%29%20Guideline.pdf.
Rumman T, Alani I, Hassan S. Coating potential of a new modified starch coating for immediate release oral tablets. Am Coat Assoc 2015; 12: 167–175.
EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS), Mortensen A, Aguilar F, et al. Re-evaluation of xanthan gum (E 415) as a food additive. EFSA J. 2017;15(7):e04909. Published 2017 Jul 14.
Sulaiman, T., and S. Sulaiman. “Review: excipients for tablet manufacturing with direct compression method”. Journal of Pharmaceutical And Sciences, Vol. 3, no. 2, Nov. 2020; pp. 64-76.
Liberman HA, Lachman L, Schwartz JB. Pharmaceutical Dosage Forms: Tablets. 2nd ed., Vol. 1. USA: Marcel Dekker; 1989.
USP37-NF32 (2014) United States Pharmacopeia 37: National Formulary 32.
Kumar, Davinder & Singh, Jasbir & Antil, Mamta & Kumar, Virender.. Quality control of tablets: A review. International Journal of Universal Pharmacy and Bio Sciences. July-August 2016,5(4).
USP: https:// www.usp. org/sites /default/ files / usp/document/ harmonization/gen-chapter /g06 _ pf_ ira_32_2_2006.pdf
USP: https://www.usp.org/sites/default/files/usp/document/harmonization/gen-chapter/april-2019-m99460.pdf
Irbesartan on : https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=2a7cc4e3-bf9e-6d21-e054-00144ff8d46c&type=display.
Dubey, Atul et al. “Improvement of tablet coating uniformity using a quality by design approach.” AAPS PharmSciTech 2012; 13(1): 231-46.
Dubey, Atul et al. “Improvement of tablet coating uniformity using a quality by design approach.” AAPS PharmSciTech 2012; 13(1) : 231-46.
Suryadevara V, Lankapalli SR, Sunkara S, Sakhamuri V, Danda H. Dissolution rate enhancement of irbesartan and development of fast-dissolving tablets. Egypt Pharmaceut J 2016;15:150-7.
Anupama B, Kurumaddali A, Bhargav SN, et al. UV spectrophotometric method for irbesartan. Int J Res Pharm Chem 2012; 2: 20–21.
Sayyed ZM, Shinde SA, Chaware VJ, et al. Development and Validation of UV-Spectrophotometric Method for Simultaneous Estimation of Amlodipine Besylate and Hydrochlorothiazide in Combined Dosage Form Including Stability Study. J Pharm Sci Biosci Res 2015; 5: 487–493.
Lopes B, Lopes L, Silva B, & Carvalho M, Schnitzler E, Lacerda, L. Xanthan gum: Properties, production conditions, quality and economic perspective J Food Nutr Res 2015; 54:185-194.
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