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Abstract

The field of pharmaceutical formulation is constantly evolving, driven by the need for improved drug delivery systems and enhanced therapeutic outcomes. One critical aspect of this evolution is the development and utilization of novel excipients. This review explores the types and examples of novel excipients that have revolutionized drug formulation in recent years. Throughout this review, we delve into the applications, advantages, and limitations of these novel excipients, highlighting their pivotal role in shaping the future of pharmaceutical formulation. The utilization of these innovative materials not only improves drug efficacy and patient compliance but also offers exciting opportunities for personalized medicine and targeted drug delivery.

Keywords

Novel excipients, Novel Excipients types, Regulation, Challenges, Soluplus, Eudracap

Reference

  1. Chaudhari SP, Patil PS. Pharmaceutical excipients: a review. Int J Adv Pharm Biol Chem. 2012 Jan;1[1]:21-34.
  2. abdul-bari mohammed abdul- mutalib. The Excipients between Effects and the Side Effects. mcrr [Internet]. 2019 May 27 [cited 2023 Jul. 28];2[5]:178-87. 
  3. Lakshmana Pramod et.al” globalregulatory perspective of bulk pharmaceutical excipients” available on www.pharmainfo.net/ review/globalregulatory perspective-bulk-pharmaceutical – excipients.
  4. Patrick J Crowley, Luigi G Martini “ excipients for pharmaceutical dosage forms” Encyclopedia of pharmaceutical technology 02 oct 2006. 
  5. Bhattacharyya L, Schuber S, Sheehan C, William R. Excipients: background/introduction. InExcipient development for pharmaceutical, biotechnology, and drug delivery systems 2006 Jul 28 [pp. 21-22]. CRC Press.
  6. Pifferi G, Restani P. The safety of pharmaceutical excipients. Il Farmaco. 2003 Aug 1;58[8]:541-50.
  7. Williams III RO, Reynolds TD, Cabelka TD, Sykora MA, Mahaguna V. Investigation of excipient type and level on drug release from controlled release tablets containing HPMC. Pharmaceutical development and technology. 2002 Jan 1;7[2]:181-93.
  8. DeMerilis C., Goldring J., Schnoeker D: Inside IPEC: New Excipient Evaluation Procedure, Pharmaceutical Technology 2008;32
  9. Ilic, I., Kasa, P., Dreu, R. et al. [2009] The compressibility and compactability of different types of lactose. Drug Dev. Ind. Pharm., 35 [10], 1271–1280.
  10. FDA, “Novel Excipient Review Program Proposal; Request for Information and Comments,” Notice, Federal Register, 84 FR 66669-66671.
  11. Guth, F., Schmeller, T., Kolter, K., 2011. Characterization Requirements for New Excipients, The international Pharmaceutical Excipients Council Europe Annual Seminar, Cannes.
  12. Brock, W., Velagaleti, R., Goldring, J.M., Osterberg, R., DeMerlis, C.C., 2009. Regulatory Update: The IPEC Novel Excipient Safety Evaluation Procedure. Pharmaceutical Technology 33: 1
  13. Guth, F., Schmeller, T., Kolter, K., 2011. Characterization Requirements for New Excipients, The international Pharmaceutical Excipients Council Europe Annual Seminar, Cannes.
  14. Committee for Medicinal Products for Human Use. Guideline on excipients in the dossier for application for marketing authorisation of a medicinal product.
  15. European Medicines Agency. Guideline on pharmaceutical development of medicines for paediatric use. EMA/CHMP/QWP/805880/2012 Rev. 2. 2013 Aug 1.
  16. Katdare A, Chaubal M, editors. Excipient development for pharmaceutical, biotechnology, and drug delivery systems. CRC Press; 2006 Jul 28.
  17. European-Medicines-Agency, 2010. Withdrawal Assessment Report for Docetaxel Mylan 10 mg/ml, powder and solvent for solution for infusion. EMEA/H/C/1193 http://www.ema.europa.eu/docs/en_GB/document_library/Application withdraw al assessment report/2010/06/WC500093289.pdf. EMA, London [accessed 10.01.2018].
  18. IPEC, 2009. IPEC Europe Approach to the Lack of a Master File System for Excipients in Europe. 
  19. Kozarewicz P, Loftsson T. Novel excipients–Regulatory challenges and perspectives–The EU insight. International Journal of Pharmaceutics. 2018 Jul 30;546[1-2]:176-9.
  20. Steinberg L, Morris AS. Adolescent development. Annual review of psychology. 2001 Feb;52[1]:83-110.
  21. BLECHER O, GOLDMAN S, MEVARECH M. High expression in Escherichia coli of the gene coding for dihydrofolate reductase of the extremely halophilic archaebacterium Haloferax volcanii: reconstitution of the active enzyme and mutation studies. European journal of biochemistry. 1993 Aug;216[1]:199-203.
  22. Rashid U, Anwar F, Moser BR, Knothe G. Moringa oleifera oil: A possible source of biodiesel. Bioresource technology. 2008 Nov 1;99[17]:8175-9.
  23. Rahman MA, Ahuja A, Baboota S, Bali V, Saigal N, Ali J. Recent advances in pelletization technique for oral drug delivery: a review. Current drug delivery. 2009 Jan 1;6[1]:122-9.
  24.  Ilic, I., Kasa, P., Dreu, R. et al. [2009] The compressibility and compactability of different types of lactose. Drug Dev. Ind. Pharm., 35 [10], 1271–1280.
  25. Doelker, E. and Gurny, R. [1987] Degrees of crystallinity and polymerization of modified cellulose powders for direct tableting. Powder Technology, 52 [3], 207–213.
  26.  Nachaegari, S. and Bansal, A.K. [2004] Coprocessed excipients for solid dosage forms.Pharm. Technol., 2004, 52–64.
  27. Saha, S. and Shahiwala, A.F. [2009]Multifunctional coprocessed excipients for improved tabletting performance [2009]. Expert Opinion on Drug Delivery, 6 [2], 197–208.
  28. The IPEC Excipient Composition Guide, 2009.
  29. Gupta, P. et al. [2006] Improved excipient functionality by coprocessing, in Excipient Development for Pharmaceutical, Biotechnology and Drug Delivery Systems [ed. Katadare A.], Informa Healthcare USA, Inc., New York.
  30. Salunkhe, K. S., Wagh, M., Jadhav, S. P., & Chaudhari, S. R. (2011). Development And Evaluation Of Spray Dried Co-Processed Excipients For Oro-Dispersible Tablet. Inventi Rapid: Pharm Tech.
  31. DeMerlis, C.C., Goldring, J.M., Velagaleti, R. et al. [2009] Regulatory update: The IPEC novel excipient safety evaluation procedure. Pharm. Tech., 33 [11], 72–82.
  32. Thompson, D.O. [2006] Cyclodextrins – enabling excipients: A case study of the development of a newexcipient – sulfobutylether ß-cyclodextrin CAPTISOL®, in ExcipientDevelopment for Pharmaceutical, Biotechnology and Drug Delivery Systems [ed. Katadare A.], Informa Healthcare USA, Inc., New York.
  33.  Brewster, M.E., Vandecruys, R., Peeters, J. et al. [2008] Comparative interaction of -hydroxypropyl-?-cyclodextrin and sulfobutylether-?-cyclodextrin with itraconazole: Phase-solubility behavior and stabilization of supersaturated drug solutions. Eur. J. Pharm. Sci., 34, 94–103.
  34. Linn, M., Collnot, E.M., Djuric, D., Hempel, K., Fabian, E., Kolter, K. and Lehr, C.M., 2012. Soluplus® as an effective absorption enhancer of poorly soluble drugs in vitro and in vivo. European Journal of Pharmaceutical Sciences, 45[3], pp.336-343.
  35. Jawed, S. and Cs, S., 2022. Exploration of parteck® SRP 80 and hypromellose for chronomodulated release of LTD4 receptor antagonist and statistical optimization using Central composite design. AAPS PharmSciTech, 23[7], p.263.
  36. Guidance for Industry: Non-Clinical Studies for the Safety Evaluation of Pharmaceutical Excipients, May 2005: 3-4.
  37. DeMerlis C, Goldring J, Velagaleti R, Brock W, Osterberg R. Regulatory update: the IPEC novel excipient safety evaluation procedure. Pharm Technol. 2009 Nov 2;33[11]:72-82.
  38. Steinberg L, Morris AS. Adolescent development. Annual review of psychology. 2001 Feb;52[1]:83-110.
  39. BLECHER O, GOLDMAN S, MEVARECH M. High expression in Escherichia coli of the gene coding for dihydrofolate reductase of the extremely halophilic archaebacterium Haloferax volcanii: reconstitution of the active enzyme and mutation studies. European journal of biochemistry. 1993 Aug;216[1]:199-203.
  40. Rashid U, Anwar F, Moser BR, Knothe G. Moringa oleifera oil: A possible source of biodiesel. Bioresource technology. 2008 Nov 1;99[17]:8175-9.
  41. Rahman MA, Ahuja A, Baboota S, Bali V, Saigal N, Ali J. Recent advances in pelletization technique for oral drug delivery: a review. Current drug delivery. 2009 Jan 1;6[1]:122-9.
  42. Bin LK, Gaurav A, Mandal UK. A review on co-processed excipients: current and future trend of excipient technology. Int J Pharm Pharm Sci. 2019.
  43. Jacob B, Bisht LK, Chandy V. Ludiflash—A Novel Excipient for Patient Friendly Dosage Form. RRJoP. 2017;7[2]:5-7.
  44. Krishna LN, Kulkarni PK, Dixit M, Lavanya D, Raavi PK. Brief introduction of natural gums, mucilages and their applications in novel drug delivery systems-a review. IJDFR. 2011 Nov;2[6]:54-71.

Photo
Vaibhav B. Gunjal
Corresponding author

Divine College of Pharmacy, Satana, Nashik, Maharashtra, India, 423301.

Photo
Darshan S. Sonawane
Co-author

Divine College of Pharmacy, Satana, Nashik, Maharashtra, India, 423301.

Photo
Samruddhi K. Ahire
Co-author

Divine College of Pharmacy, Satana, Nashik, Maharashtra, India, 423301.

Photo
Pranav K. Jadhav
Co-author

Divine College of Pharmacy, Satana, Nashik, Maharashtra, India, 423301.

Photo
Yashashri K. Deore
Co-author

Divine College of Pharmacy, Satana, Nashik, Maharashtra, India, 423301.

Photo
Shivaraj P. Jadhav
Co-author

Divine College of Pharmacy, Satana, Nashik, Maharashtra, India, 423301.

Photo
Dhananjay M. Patil
Co-author

Divine College of Pharmacy, Satana, Nashik, Maharashtra, India, 423301.

Vaibhav B. Gunjal*, Darshan S. Sonawane, Samruddhi K. Ahire, Pranav K. Jadhav, Yashashri K. Deore, Shivaraj P. Jadhav, Dhananjay M. Patil, A Review On Novel Excipients, Int. J. in Pharm. Sci., 2023, Vol 1, Issue 9, 304-320. https://doi.org/10.5281/zenodo.8344687

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