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


Дәйексөз келтіру

Толық мәтін

Аннотация

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.

Авторлар туралы

Aliasgar Shahiwala

Pharmaceutics Department, Dubai Pharmacy College

Хат алмасуға жауапты Автор.
Email: info@benthamscience.net

Әдебиет тізімі

  1. Dahiya M, Saha S, Shahiwala A. A review on mouth dissolving films. Curr Drug Deliv 2009; 6(5): 469-76. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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) doi: 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. doi: 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. doi: 10.1016/j.compositesb.2016.11.016

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