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Thermal Stability and Drug-Excipient Compatibility Studies of Peppermint and Caraway Oils for Formulation of Chewable Tablets
Corresponding Author(s) : Nikhil K. Sachan
Asian Journal of Chemistry,
Vol. 25 No. 11 (2013): Vol 25 Issue 11
Abstract
Drug delivery is highly innovative in terms of materials to assist delivery, excipients and technology which allows release of drugs in a manner desired for improved therapeutic efficacy, safety and patient compliance. Among many other factors cost of non-compliance alone estimated to be ca. 13 % of total healthcare expenditure per year. Providing patients with simplified oral medications that will improve compliance and thus result more effective treatment has been one of the major drivers for innovation in the oral controlled drug delivery market. In this connection the oral chewable tablets were investigated as possible alternative formulations for the delivery essential oils known to be effective for the treatment of various ailments and have been administered traditionally as aromatic waters, elixirs, or more recently in the soft gelatin capsules. Now-a-days when people are increasingly taking several products as breath freshener, the present concept to formulate these essential oils in the form of chewable dosage forms so that these can be administered for such therapeutic uses and can provide simultaneously breath freshness to consumer in view of the urban lifestyle. This paper discuss the thermal stability and drug-excipient compatibility studies of peppermint and caraway oils for formulation of chewable tablets as alternative dosage form towards improved patient compliance and market viability.
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- N.K. Sachan and A. Bhattacharya, J. Assam Sci. Soc., 47, 34 (2006).
- A.K. Sachan, N.K. Sachan, S. Kumar, A. Sachan and S.S. Gangwar, Eur. J. Sci. Res., 46, 194 (2010).
- W.N. Charman, H.K. Chan, B.C. Finnin and S.A. Charman, Drug Dev. Res., 46, 316 (1999).
- J.T. Coon and E. Erenst, Alimen. Pharmacol. Therap., 16, 1689 (2002).
- British Herbal Medicine Association. British Herbal Pharmacopoeia, Part II. West Yorks, England: BHMA Publishers, pp. 23-25 (1979).
- R.C. Wren, Potter's New Cyclopaedia of Botanical Drugs and Preparation, Essex, England: CW Daniel Co., pp. 59-60 (1985).
- M. Wichtl, Herbal Drugs and Phytopharmaceuticals, Boca Raton, FL: CRC Press, pp. 128-129 (1994).
- B. May, H.D. Kuntz, M. Kieser and S. Kohler, Arzneimittel-Forsch, 46, 1149 (1996).
- New England Healthcare Institute [NEHI, Report, New Research on Patient Medication Adherence, Report: Cambridge MA. September 23, (2010) Available through: http://www.nehi.net/ (Accessed on May 29, 2011).
- G.S. Rekhi, Advances in Solid Dose Oral drug Delivery. In: Oral Drug Delivery and Advanced Excipients, Frederick Furness Publishing, East Sussex, UK, pp. 14-18 (2010). Available through: www.ondrugdelivery.com/ (Accessed on May 29, 2011).
- A.K. Sachan, Alternative Dosage Forms for Delivery of Essential OilsChewable Tablets, M.Pharm, Thesis, India: Bundelkhand University (2005).
- N.K. Sachan, S.K. Ghosh and S. Pushkar, In eds.: A. Shrivastava and V. Nigam, Science of Polymeric Plant Based Excipients in Pharmaceutical Drug Delivery Systems, Proceedings of National Seminar on Global Perspectives of Biological Research in the Present Scenario, India: D.G.P.G. College, Kanpur, pp. 135-150 (2010).
- ICH Harmonized Tripartite Guidelines: International Conference on Harmonization (ICH)-Guidance for Industry: Q1A(R2) Stability Testing of New Drug Substances and Products (2003) Available at: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm128204.pdf (Assessed, September 19, 2010).
- L. Bhattacharya, S. Schuber, S. Sheehan and R. William, In eds.:A. Katdare and M.V. Chaubal, Excipients: Background/Introduction, Excipients Development for Pharmaceutical, Biotechnology and Drug Delivery System, New York: Informa Health Care, pp. 1-2 (2006).
- IPEC: Qualification of Excipients for Use in Pharmaceuticals, International Pharmaceutical Excipients Council, Europe (2008), Available at: www.ipec-europe.org (Accessed on 27th August 2010)
- H. Liberman, L. Lachman and J.B. Schwartz, Pharmaceutical Dosage Forms: Tablets, New York: Marcel Dekker Publisher, Vol. 1, edn. 2 (2005).
- S. Yoshioka and V.J. Stella, Stability of Drugs and Dosage Forms, New York: Kluwer Academic Publishers, Vol. V-VI, pp. 1-2 (2002).
- N.K. Sachan and D. Singh, J. Assam Sci. Soc., 46, 20 (2005).
- B. Roger, T. Richard, H. Kimberly and A. Attaran, Malaria J., 8, 1 (2009).
- P. Jin, S. Madieh and L.L. Augsburger, AAPS Pharm. Sci. Technol., 8, 105 (2007).
- S. Klick, P.G. Muijselaar, J. Waterval, T. Eichinger, C. Korn, T.K. Gerding, A.J. Debets, C. Sänger-van de Griend, C. van den Beld, G.W. Somsen and G.J. De Jong, Pharm. Technol., 2, 48 (2005).
References
N.K. Sachan and A. Bhattacharya, J. Assam Sci. Soc., 47, 34 (2006).
A.K. Sachan, N.K. Sachan, S. Kumar, A. Sachan and S.S. Gangwar, Eur. J. Sci. Res., 46, 194 (2010).
W.N. Charman, H.K. Chan, B.C. Finnin and S.A. Charman, Drug Dev. Res., 46, 316 (1999).
J.T. Coon and E. Erenst, Alimen. Pharmacol. Therap., 16, 1689 (2002).
British Herbal Medicine Association. British Herbal Pharmacopoeia, Part II. West Yorks, England: BHMA Publishers, pp. 23-25 (1979).
R.C. Wren, Potter's New Cyclopaedia of Botanical Drugs and Preparation, Essex, England: CW Daniel Co., pp. 59-60 (1985).
M. Wichtl, Herbal Drugs and Phytopharmaceuticals, Boca Raton, FL: CRC Press, pp. 128-129 (1994).
B. May, H.D. Kuntz, M. Kieser and S. Kohler, Arzneimittel-Forsch, 46, 1149 (1996).
New England Healthcare Institute [NEHI, Report, New Research on Patient Medication Adherence, Report: Cambridge MA. September 23, (2010) Available through: http://www.nehi.net/ (Accessed on May 29, 2011).
G.S. Rekhi, Advances in Solid Dose Oral drug Delivery. In: Oral Drug Delivery and Advanced Excipients, Frederick Furness Publishing, East Sussex, UK, pp. 14-18 (2010). Available through: www.ondrugdelivery.com/ (Accessed on May 29, 2011).
A.K. Sachan, Alternative Dosage Forms for Delivery of Essential OilsChewable Tablets, M.Pharm, Thesis, India: Bundelkhand University (2005).
N.K. Sachan, S.K. Ghosh and S. Pushkar, In eds.: A. Shrivastava and V. Nigam, Science of Polymeric Plant Based Excipients in Pharmaceutical Drug Delivery Systems, Proceedings of National Seminar on Global Perspectives of Biological Research in the Present Scenario, India: D.G.P.G. College, Kanpur, pp. 135-150 (2010).
ICH Harmonized Tripartite Guidelines: International Conference on Harmonization (ICH)-Guidance for Industry: Q1A(R2) Stability Testing of New Drug Substances and Products (2003) Available at: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm128204.pdf (Assessed, September 19, 2010).
L. Bhattacharya, S. Schuber, S. Sheehan and R. William, In eds.:A. Katdare and M.V. Chaubal, Excipients: Background/Introduction, Excipients Development for Pharmaceutical, Biotechnology and Drug Delivery System, New York: Informa Health Care, pp. 1-2 (2006).
IPEC: Qualification of Excipients for Use in Pharmaceuticals, International Pharmaceutical Excipients Council, Europe (2008), Available at: www.ipec-europe.org (Accessed on 27th August 2010)
H. Liberman, L. Lachman and J.B. Schwartz, Pharmaceutical Dosage Forms: Tablets, New York: Marcel Dekker Publisher, Vol. 1, edn. 2 (2005).
S. Yoshioka and V.J. Stella, Stability of Drugs and Dosage Forms, New York: Kluwer Academic Publishers, Vol. V-VI, pp. 1-2 (2002).
N.K. Sachan and D. Singh, J. Assam Sci. Soc., 46, 20 (2005).
B. Roger, T. Richard, H. Kimberly and A. Attaran, Malaria J., 8, 1 (2009).
P. Jin, S. Madieh and L.L. Augsburger, AAPS Pharm. Sci. Technol., 8, 105 (2007).
S. Klick, P.G. Muijselaar, J. Waterval, T. Eichinger, C. Korn, T.K. Gerding, A.J. Debets, C. Sänger-van de Griend, C. van den Beld, G.W. Somsen and G.J. De Jong, Pharm. Technol., 2, 48 (2005).