Login Register Cart 0
Generic placeholder image

Current Pharmaceutical Design

Editor-in-Chief

ISSN (Print): 1381-6128
ISSN (Online): 1873-4286

Back
Journal Home About Journal Editorial Board Journal Insight Current Issue Volumes/Issues
Subscribe
Research Article

Studies in Solid Solution Formation between Acetaminophen and Povidone and Mouth-dissolving Strip Formulation

Author(s): Aliasgar Shahiwala*

Volume 30, Issue 15, 2024

Published on: 28 March, 2024

Page: [1200 - 1208] Pages: 9

DOI: 10.2174/0113816128297499240321034304

Price: $65

Open Access Journals Promotions 2
Abstract

Introduction: This invention reports the solubilization of Acetaminophen (ACM) within the Povidone (PVP K30) in the solid state for the first time.

Methods: First-generation solid dispersions (SDs) were attempted with a different ratio of PVP K:30:ACM. SDs prepared were transparent, suggesting a solid solution (SS) formation, which was a serendipitous discovery. A minimum ratio of 1.25:1 PVP K30: ACM was required to form stable SS, suggesting discontinuous SS. A computational complex prediction tool, fourier transform infrared spectroscopy (FTIR), and differential scanning calorimetry (DSC) confirmed the SS formation.

Results: The oral strip formulation was developed from the PVP K30: ACM SS using Polyvinyl alcohol as a film-former found to be optimum concerning physicochemical properties, offering rapid drug dissolution and taste masking.

Conclusion: The designed strip is suitable for delivering a child's dose (100-150 mg). However, the developed SS can be formulated as tablets, capsules, or oral dissolving tablets to deliver adult doses with improved therapeutic benefits and patient compliance.

Keywords: Solid dispersion, solid solution, paracetamol, mouth dissolving strips, Acetaminophen, Povidone.

« Previous Next »
[1]
Dahiya M, Saha S, Shahiwala A. A review on mouth dissolving films. Curr Drug Deliv 2009; 6(5): 469-76.
[http://dx.doi.org/10.2174/156720109789941713] [PMID: 19751197]
[2]
Panda BP, Dey NS, Rao MEB. Development of innovative orally fast disintegrating film dosage forms: A review. Int J Pharm Sci Nanotechnol 2012; 5(2): 1666-74.
[http://dx.doi.org/10.37285/ijpsn.2012.5.2.2]
[3]
Sareen S, Mathew G, Joseph L. Improvement in solubility of poor water-soluble drugs by solid dispersion. Int J Pharm Investig 2012; 2(1): 12.
[http://dx.doi.org/10.4103/2230-973X.96921]
[4]
Kaushik R, Budhwar V, Kaushik D. An overview on recent patents and technologies on solid dispersion. Recent Pat Drug Deliv Formul 2020; 14(1): 63-74.
[http://dx.doi.org/10.2174/22124039MTAzoNzEwy] [PMID: 31951172]
[5]
Singh G, Kaur L, Gupta GD, Sharma S. Enhancement of the solubility of poorly water soluble drugs through solid dispersion: A comprehensive review. Indian J Pharm Sci 2017; 79(5): 674-87.
[http://dx.doi.org/10.4172/pharmaceutical-sciences.1000279]
[6]
Thakur D, Sharma R. Solid dispersion a novel approach for enhancement of solubility and dissolution rate: A review. IJPBR 2019; 7(03): 05.
[7]
Liu Y, Guo H. Smart intraoral systems for advanced drug delivery. MedComm Biomater Appl 2022; 3(1): e19.
[8]
Sudheer P, Shrestha S, Narayana KA. Amorphous solid dispersion based oral disintegrating film of ezetimibe: Development and evaluation. Drug Metab Lett 2021; 14(1): 66-79.
[http://dx.doi.org/10.2174/1872312814666200901182517] [PMID: 32875994]
[9]
Sana S, Salwa , Shirodkar RK, Kumar L, Verma R. Enhancement of solubility and dissolution rate using tailored rapidly dissolving oral films containing felodipine solid dispersion: In vitro characterization and ex vivo studies. J Pharm Innov 2023; 18(3): 1241-52.
[http://dx.doi.org/10.1007/s12247-023-09716-7]
[10]
Douroumis D. Practical approaches of taste masking technologies in oral solid forms. Expert Opin Drug Deliv 2007; 4(4): 417-26.
[http://dx.doi.org/10.1517/17425247.4.4.417]
[11]
Sohi H, Sultana Y, Khar RK. Taste masking technologies in oral pharmaceuticals: Recent developments and approaches. Drug Dev Ind Pharm 2004; 30(5): 429-48.
[http://dx.doi.org/10.1081/DDC-120037477]
[12]
Kalantzi L, Reppas C, Dressman JB, et al. Biowaiver monographs for immediate release solid oral dosage forms: Acetaminophen (paracetamol). J Pharm Sci 2006; 95(1): 4-14.
[http://dx.doi.org/10.1002/jps.20477] [PMID: 16307451]
[13]
Sharma A, Jain CP. Preparation and characterization of solid dispersions of carvedilol with PVP K30. Res Pharm Sci 2010; 5(1): 49-56.
[14]
Wei JN, Duvenaud D, Guzik AA. Neural networks for the prediction of organic chemistry reactions. ACS Cent Sci 2016; 2(10): 725-32.
[http://dx.doi.org/10.1021/acscentsci.6b00219] [PMID: 27800555]
[15]
Elagamy HI, Essa EA, Nouh A, Maghraby EGM. Development and evaluation of rapidly dissolving buccal films of naftopidil: In vitro and in vivo evaluation. Drug Dev Ind Pharm 2019; 45(10): 1695-706.
[http://dx.doi.org/10.1080/03639045.2019.1656734] [PMID: 31418592]
[16]
Shah KA, Li G, Song L, et al. Rizatriptan-loaded oral fast dissolving films: Design and characterizations. Pharmaceutics 2022; 14(12): 2687.
[http://dx.doi.org/10.3390/pharmaceutics14122687] [PMID: 36559181]
[17]
Shah KA, Gao B, Kamal R, et al. Development and characterizations of pullulan and maltodextrin-based oral fast-dissolving films employing a box-behnken experimental design. Materials 2022; 15(10): 3591.
[18]
Fetih G, Allam A. Sublingual fast dissolving niosomal films for enhanced bioavailability and prolonged effect of metoprolol tartrate. Drug Des Devel Ther 2016; 10: 2421-33.
[http://dx.doi.org/10.2147/DDDT.S113775] [PMID: 27536063]
[19]
Lai KL, Fang Y, Han H, et al. Orally-dissolving film for sublingual and buccal delivery of ropinirole. Colloids Surf B Biointerfaces 2018; 163: 9-18.
[http://dx.doi.org/10.1016/j.colsurfb.2017.12.015] [PMID: 29268211]
[20]
Londhe V, Shirsat R. Formulation and characterization of fast-dissolving sublingual film of iloperidone using box-behnken design for enhancement of oral bioavailability. AAPS PharmSciTech 2018; 19(3): 1392-400.
[http://dx.doi.org/10.1208/s12249-018-0954-y] [PMID: 29396734]
[21]
Singhal D, Curatolo W. Drug polymorphism and dosage form design: A practical perspective. Adv Drug Deliv Rev 2004; 56(3): 335-47.
[http://dx.doi.org/10.1016/j.addr.2003.10.008] [PMID: 14962585]
[22]
Forster A, Hempenstall J, Rades T. Characterization of glass solutions of poorly water-soluble drugs produced by melt extrusion with hydrophilic amorphous polymers. J Pharm Pharmacol 2010; 53(3): 303-15.
[http://dx.doi.org/10.1211/0022357011775532] [PMID: 11291745]
[23]
Crowley KJ, Zografi G. The effect of low concentrations of molecularly dispersed poly(vinylpyrrolidone) on indomethacin crystallization from the amorphous state. Pharm Res 2003; 20(9): 1417-22.
[http://dx.doi.org/10.1023/A:1025706110520] [PMID: 14567636]
[24]
Simonelli AP, Mehta SC, Higuchi WI. Dissolution rates of high energy sulfathiazole-povidone coprecipitates II: Characterization of form of drug controlling its dissolution rate via solubility studies. J Pharm Sci 1976; 65(3): 355-61.
[http://dx.doi.org/10.1002/jps.2600650310] [PMID: 1263082]
[25]
Rask MB, Knopp MM, Olesen NE, Holm R, Rades T. Influence of PVP/VA copolymer composition on drug-polymer solubility. Eur J Pharm Sci 2016; 85: 10-7.
[http://dx.doi.org/10.1016/j.ejps.2016.01.026] [PMID: 26826280]
[26]
Mahieu A, Willart JF, Dudognon E, Danède F, Descamps M. A new protocol to determine the solubility of drugs into polymer matrixes. Mol Pharm 2013; 10(2): 560-6.
[http://dx.doi.org/10.1021/mp3002254] [PMID: 23253068]
[27]
Marsac PJ, Shamblin SL, Taylor LS. Theoretical and practical approaches for prediction of drug-polymer miscibility and solubility. Pharm Res 2006; 23(10): 2417-26.
[http://dx.doi.org/10.1007/s11095-006-9063-9] [PMID: 16933098]
[28]
Tekade AR, Yadav JN. A review on solid dispersion and carriers used therein for solubility enhancement of poorly water soluble drugs. Adv Pharm Bull 2020; 10(3): 359-69.
[http://dx.doi.org/10.34172/apb.2020.044]
[29]
Yadav B, Tanwar YS. Applications of solid dispersions. J Chem Pharm Res 2015; 7(2): 965-78.
[30]
Goldberg AH, Gibaldi M, Kanig JL. Increasing dissolution rates and gastrointestinal absorption of drugs via solid solutions and eutectic mixtures. I. Theoretical considerations and discussion of the literature. J Pharm Sci 1965; 54(8): 1145-8.
[http://dx.doi.org/10.1002/jps.2600540810] [PMID: 5882218]
[31]
Simonelli AP, Mehta SC, Higuchi WI. Dissolution rates of high energy polyvinylpyrrolidone (PVP)-sulfathiazole coprecipitates. J Pharm Sci 1969; 58(5): 538-49.
[http://dx.doi.org/10.1002/jps.2600580503] [PMID: 5796439]
[32]
Knopp MM, Tajber L, Tian Y, et al. Comparative study of different methods for the prediction of drug-polymer solubility. Mol Pharm 2015; 12(9): 3408-19.
[http://dx.doi.org/10.1021/acs.molpharmaceut.5b00423] [PMID: 26214347]
[33]
Zaman M, Hassan R, Razzaq S, et al. Fabrication of polyvinyl alcohol based fast dissolving oral strips of sumatriptan succinate and metoclopramide HCL. Sci Prog 2020; 103(4)
[http://dx.doi.org/10.1177/0036850420964302] [PMID: 33151131]
[34]
Roy A, Ghosh A, Datta S, et al. Effects of plasticizers and surfactants on the film forming properties of hydroxypropyl methylcellulose for the coating of diclofenac sodium tablets. Saudi Pharm J 2009; 17(3): 233-41.
[http://dx.doi.org/10.1016/j.jsps.2009.08.004] [PMID: 23964166]
[35]
Nešić A, Ružić J, Gordić M, Ostojić S, Micić D, Onjia A. Pectin-polyvinylpyrrolidone films: A sustainable approach to the development of biobased packaging materials. Compos, Part B Eng 2017; 110: 56-61.
[http://dx.doi.org/10.1016/j.compositesb.2016.11.016]

Rights & Permissions Print Cite
Article Metrics
18
4
Wayfinder Image
Open Access Journals Promotions
World Antimicrobial Awareness Week
© 2024 Bentham Science Publishers | Privacy Policy