Development and characterization of orodispersible tablets of aceclofenac by sublimation technique

R. Kumar, M.B. Patil, S.R. Patil, M.S. Paschapur, R. Mahalaxmi

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

The purpose of this investigation was to develop fast dissolving tablets of aceclofenac using camphor as a subliming agent. Orodispersible tablets of aceclofenac were prepared by wet granulation technique using camphor as subliming agent and sodium starch glycolate together with crosscarmellose sodium as superdisintegrants. Camphor was sublimed from the granules by exposing the granules to vacuum. The porous granules were then compressed in to tablets. Alternatively, tablets were first prepared and later exposed to vacuum. The formulations were evaluated for weight variation, hardness, friability, drug content, wetting time, in vitro and in-vivo dispersion, mouth feel and in vitro dissolution. All the formulations showed low weight variation with dispersion time less than 55 seconds and rapid in vitro dissolution. Sublimation of camphor from tablets resulted in superior tablets as compared with the tablets prepared from granules that were exposed to vacuum. The results revealed that the tablets containing subliming agent had a good dissolution profile. The drug content of all the formulations was within the acceptable limits of the United States Pharmacopoeia XXVII. The optimized formulation showed good release profile with maximum drug being released at all time intervals. It was concluded that fast dissolving tablets with improved aceclofenac dissolution could be prepared by sublimation of tablets containing suitable subliming agent. This work helped in understanding the effect of formulation processing variables especially the subliming agent on the drug release profile. The present study demonstrated potentials for rapid absorption, improved bioavailability, effective therapy and patient compliance.
Original languageEnglish
Pages (from-to)210-214
Number of pages5
JournalInternational Journal of PharmTech Research
Volume1
Issue number2
Publication statusPublished - 2009

Fingerprint

Sublimation
Tablets
Camphor
Vacuum
aceclofenac
Pharmaceutical Preparations
Weights and Measures
Pharmacopoeias
Hardness
Patient Compliance
Biological Availability
Mouth
Sodium

Cite this

@article{b19a1b7f2161483fa927d95536bad2b2,
title = "Development and characterization of orodispersible tablets of aceclofenac by sublimation technique",
abstract = "The purpose of this investigation was to develop fast dissolving tablets of aceclofenac using camphor as a subliming agent. Orodispersible tablets of aceclofenac were prepared by wet granulation technique using camphor as subliming agent and sodium starch glycolate together with crosscarmellose sodium as superdisintegrants. Camphor was sublimed from the granules by exposing the granules to vacuum. The porous granules were then compressed in to tablets. Alternatively, tablets were first prepared and later exposed to vacuum. The formulations were evaluated for weight variation, hardness, friability, drug content, wetting time, in vitro and in-vivo dispersion, mouth feel and in vitro dissolution. All the formulations showed low weight variation with dispersion time less than 55 seconds and rapid in vitro dissolution. Sublimation of camphor from tablets resulted in superior tablets as compared with the tablets prepared from granules that were exposed to vacuum. The results revealed that the tablets containing subliming agent had a good dissolution profile. The drug content of all the formulations was within the acceptable limits of the United States Pharmacopoeia XXVII. The optimized formulation showed good release profile with maximum drug being released at all time intervals. It was concluded that fast dissolving tablets with improved aceclofenac dissolution could be prepared by sublimation of tablets containing suitable subliming agent. This work helped in understanding the effect of formulation processing variables especially the subliming agent on the drug release profile. The present study demonstrated potentials for rapid absorption, improved bioavailability, effective therapy and patient compliance.",
author = "R. Kumar and M.B. Patil and S.R. Patil and M.S. Paschapur and R. Mahalaxmi",
note = "Cited By :5 Export Date: 10 November 2017 Correspondence Address: Kumar, R.; Department of Pharmaceutics, K.L.E.S's College of Pharmacy, Ankola, India References: Chang, R., Guo, X., Burnside, B., Couch, R., A review of fast dissolving tablets (2000) Pharm Tech North Am, 12, pp. 52-58; Bi, Y., Sunada, H., Yonezawa, Y., Danjo, K., Otsuka, A., Iida, K., Preparation and evaluation of a compressed tablet rapidly disintegrating in the oral cavity (1996) Chemical and Pharmaceutical Bulletin, 44 (11), pp. 2121-2127; Mishra, D.N., Bindal, M., Singh, S.K., Vijaya Kumar, S.G., Spray dried excipient base: A novel technique for the formulation of orally disintegrating tablets (2006) Chemical and Pharmaceutical Bulletin, 54 (1), pp. 99-102. , http://www.jstage.jst.go.jp/article/cpb/54/1/99/_pdf, DOI 10.1248/cpb.54.99; Fu, Y., Jeong, S.H., Park, K., Fast-melting tablets based on highly plastic granules (2005) Journal of Controlled Release, 109 (1-3), pp. 203-210. , DOI 10.1016/j.jconrel.2005.09.021, PII S016836590500492X; Omaima, A.S., Mohammed, A.H., Nagia, A.M., Ahmed, S.Z., Formulation and optimization of mouth dissolve tablets containing rofecoxib solid dispersion (2006) AAPS PharmSciTech, 7, p. 55; Gohel, M., Patel, M., Amin, A., Agrawal, R., Dave, R., Bariya, N., Formulation design and optimization of mouth dissolve tablets of nimesulide using vacuum drying technique (2004) AAPS PharmSciTech, 5 (3), p. 36. , http://www.aapspharmscitech.org/view.asp?art=pt050336&pdf=yes; Suresh, S., Pandit, V., Joshi, H., Preparation and evaluation of mouth dissolving tablets of salbutamol sulphate (2007) Indian Journal of Pharmaceutical Sciences, 69 (3), pp. 467-469; Heinemann, H., Rothe, W., Preparation of Porous Tablets, , US patent 3 885 026. May 20, 1975; Knistch, A., Hagen, E., Munz, H.D., Production of Porous Tablets, , US patent 4 134 843. January 16, 1979; Roser, B.J., Blair, J., Rapidly Soluble Oral Dosage Forms, Methods of Making the Same and Composition Thereof, , US patent 5 762 961, June 9, 1998; Ahmed, I.S., Fatahalla, F.A., Pilot study of relative bioavailability of two oral formulations of ketoprofen in healthy subjects, a fast dissolving lyophilized tablet as compared to immediate release tablet (2007) Drug Develop Ind Pharm, 33, pp. 505-511; Ahmed, I.S., Nafadi, M.M., Fatahalla, F.A., Formulation of fast dissolving ketoprofen tablet using freeze-drying in blister technique (2006) Drug Develop Ind Pharm, 32, pp. 437-442; Corveleyn, S., Remon, J.P., Formulation and production of rapidly disintegrating tablets by lyophilisation using hydrochlorothiazide as a model drug (1997) International Journal of Pharmaceutics, 152 (2), pp. 215-225. , DOI 10.1016/S0378-5173(97)00092-6, PII S0378517397000926; Remon, J.P., Corveleyn, S., Freeze-dried Rapidly Disintegrating Tablets, , US patent 6 010 719, January 4, 2000; Hinz, B., Auge, D., Rau, T., Rietbrock, S., Brune, K., Werner, U., Simultaneous determination of aceclofenac and three of its metabolites in human plasma by high-performance liquid chromatography (2003) Biomedical Chromatography, 17 (4), pp. 268-275. , DOI 10.1002/bmc.243; Legrand, E., Aceclofenac in the management of inflammatory pain (2004) Exp Opin Pharmacother, 5, pp. 1347-1357; Yong, C.S., Oh, Y.K., Lee, K.H., Park, S.M., Park, Y.J., Gil, Y.S., Trials of clear aceclofenac- Loaded soft capsules with accelerated oral absorption in human subjects (2005) Int J Pharm, 302, pp. 78-83; Marshall, K., Lachman, N., Liberman, H.A., (1987) The Theory and Practice of Industrial Pharmacy, pp. 66-69. , 3rd Ed, Varghese Publishing House, Mumbai; Kimura, S., Imai, T., Otagiri, M., Pharmaceutical evaluation of Ibuprofen syrup containing low molecular weight gelatin (1992) J. Pharm. Sci., 81, pp. 141-144; Yunxia, B., Yorinobu, Y., Kazumi, D., Akinobu, O., Preparation and evaluation of oral tablet rapidly dissolving in oral cavity (1996) Chem. Pharm. Bull., 44 (11), pp. 2121-2127",
year = "2009",
language = "English",
volume = "1",
pages = "210--214",
journal = "International Journal of PharmTech Research",
issn = "0974-4304",
publisher = "Sphinx Knowledge House",
number = "2",

}

Development and characterization of orodispersible tablets of aceclofenac by sublimation technique. / Kumar, R.; Patil, M.B.; Patil, S.R.; Paschapur, M.S.; Mahalaxmi, R.

In: International Journal of PharmTech Research, Vol. 1, No. 2, 2009, p. 210-214.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Development and characterization of orodispersible tablets of aceclofenac by sublimation technique

AU - Kumar, R.

AU - Patil, M.B.

AU - Patil, S.R.

AU - Paschapur, M.S.

AU - Mahalaxmi, R.

N1 - Cited By :5 Export Date: 10 November 2017 Correspondence Address: Kumar, R.; Department of Pharmaceutics, K.L.E.S's College of Pharmacy, Ankola, India References: Chang, R., Guo, X., Burnside, B., Couch, R., A review of fast dissolving tablets (2000) Pharm Tech North Am, 12, pp. 52-58; Bi, Y., Sunada, H., Yonezawa, Y., Danjo, K., Otsuka, A., Iida, K., Preparation and evaluation of a compressed tablet rapidly disintegrating in the oral cavity (1996) Chemical and Pharmaceutical Bulletin, 44 (11), pp. 2121-2127; Mishra, D.N., Bindal, M., Singh, S.K., Vijaya Kumar, S.G., Spray dried excipient base: A novel technique for the formulation of orally disintegrating tablets (2006) Chemical and Pharmaceutical Bulletin, 54 (1), pp. 99-102. , http://www.jstage.jst.go.jp/article/cpb/54/1/99/_pdf, DOI 10.1248/cpb.54.99; Fu, Y., Jeong, S.H., Park, K., Fast-melting tablets based on highly plastic granules (2005) Journal of Controlled Release, 109 (1-3), pp. 203-210. , DOI 10.1016/j.jconrel.2005.09.021, PII S016836590500492X; Omaima, A.S., Mohammed, A.H., Nagia, A.M., Ahmed, S.Z., Formulation and optimization of mouth dissolve tablets containing rofecoxib solid dispersion (2006) AAPS PharmSciTech, 7, p. 55; Gohel, M., Patel, M., Amin, A., Agrawal, R., Dave, R., Bariya, N., Formulation design and optimization of mouth dissolve tablets of nimesulide using vacuum drying technique (2004) AAPS PharmSciTech, 5 (3), p. 36. , http://www.aapspharmscitech.org/view.asp?art=pt050336&pdf=yes; Suresh, S., Pandit, V., Joshi, H., Preparation and evaluation of mouth dissolving tablets of salbutamol sulphate (2007) Indian Journal of Pharmaceutical Sciences, 69 (3), pp. 467-469; Heinemann, H., Rothe, W., Preparation of Porous Tablets, , US patent 3 885 026. May 20, 1975; Knistch, A., Hagen, E., Munz, H.D., Production of Porous Tablets, , US patent 4 134 843. January 16, 1979; Roser, B.J., Blair, J., Rapidly Soluble Oral Dosage Forms, Methods of Making the Same and Composition Thereof, , US patent 5 762 961, June 9, 1998; Ahmed, I.S., Fatahalla, F.A., Pilot study of relative bioavailability of two oral formulations of ketoprofen in healthy subjects, a fast dissolving lyophilized tablet as compared to immediate release tablet (2007) Drug Develop Ind Pharm, 33, pp. 505-511; Ahmed, I.S., Nafadi, M.M., Fatahalla, F.A., Formulation of fast dissolving ketoprofen tablet using freeze-drying in blister technique (2006) Drug Develop Ind Pharm, 32, pp. 437-442; Corveleyn, S., Remon, J.P., Formulation and production of rapidly disintegrating tablets by lyophilisation using hydrochlorothiazide as a model drug (1997) International Journal of Pharmaceutics, 152 (2), pp. 215-225. , DOI 10.1016/S0378-5173(97)00092-6, PII S0378517397000926; Remon, J.P., Corveleyn, S., Freeze-dried Rapidly Disintegrating Tablets, , US patent 6 010 719, January 4, 2000; Hinz, B., Auge, D., Rau, T., Rietbrock, S., Brune, K., Werner, U., Simultaneous determination of aceclofenac and three of its metabolites in human plasma by high-performance liquid chromatography (2003) Biomedical Chromatography, 17 (4), pp. 268-275. , DOI 10.1002/bmc.243; Legrand, E., Aceclofenac in the management of inflammatory pain (2004) Exp Opin Pharmacother, 5, pp. 1347-1357; Yong, C.S., Oh, Y.K., Lee, K.H., Park, S.M., Park, Y.J., Gil, Y.S., Trials of clear aceclofenac- Loaded soft capsules with accelerated oral absorption in human subjects (2005) Int J Pharm, 302, pp. 78-83; Marshall, K., Lachman, N., Liberman, H.A., (1987) The Theory and Practice of Industrial Pharmacy, pp. 66-69. , 3rd Ed, Varghese Publishing House, Mumbai; Kimura, S., Imai, T., Otagiri, M., Pharmaceutical evaluation of Ibuprofen syrup containing low molecular weight gelatin (1992) J. Pharm. Sci., 81, pp. 141-144; Yunxia, B., Yorinobu, Y., Kazumi, D., Akinobu, O., Preparation and evaluation of oral tablet rapidly dissolving in oral cavity (1996) Chem. Pharm. Bull., 44 (11), pp. 2121-2127

PY - 2009

Y1 - 2009

N2 - The purpose of this investigation was to develop fast dissolving tablets of aceclofenac using camphor as a subliming agent. Orodispersible tablets of aceclofenac were prepared by wet granulation technique using camphor as subliming agent and sodium starch glycolate together with crosscarmellose sodium as superdisintegrants. Camphor was sublimed from the granules by exposing the granules to vacuum. The porous granules were then compressed in to tablets. Alternatively, tablets were first prepared and later exposed to vacuum. The formulations were evaluated for weight variation, hardness, friability, drug content, wetting time, in vitro and in-vivo dispersion, mouth feel and in vitro dissolution. All the formulations showed low weight variation with dispersion time less than 55 seconds and rapid in vitro dissolution. Sublimation of camphor from tablets resulted in superior tablets as compared with the tablets prepared from granules that were exposed to vacuum. The results revealed that the tablets containing subliming agent had a good dissolution profile. The drug content of all the formulations was within the acceptable limits of the United States Pharmacopoeia XXVII. The optimized formulation showed good release profile with maximum drug being released at all time intervals. It was concluded that fast dissolving tablets with improved aceclofenac dissolution could be prepared by sublimation of tablets containing suitable subliming agent. This work helped in understanding the effect of formulation processing variables especially the subliming agent on the drug release profile. The present study demonstrated potentials for rapid absorption, improved bioavailability, effective therapy and patient compliance.

AB - The purpose of this investigation was to develop fast dissolving tablets of aceclofenac using camphor as a subliming agent. Orodispersible tablets of aceclofenac were prepared by wet granulation technique using camphor as subliming agent and sodium starch glycolate together with crosscarmellose sodium as superdisintegrants. Camphor was sublimed from the granules by exposing the granules to vacuum. The porous granules were then compressed in to tablets. Alternatively, tablets were first prepared and later exposed to vacuum. The formulations were evaluated for weight variation, hardness, friability, drug content, wetting time, in vitro and in-vivo dispersion, mouth feel and in vitro dissolution. All the formulations showed low weight variation with dispersion time less than 55 seconds and rapid in vitro dissolution. Sublimation of camphor from tablets resulted in superior tablets as compared with the tablets prepared from granules that were exposed to vacuum. The results revealed that the tablets containing subliming agent had a good dissolution profile. The drug content of all the formulations was within the acceptable limits of the United States Pharmacopoeia XXVII. The optimized formulation showed good release profile with maximum drug being released at all time intervals. It was concluded that fast dissolving tablets with improved aceclofenac dissolution could be prepared by sublimation of tablets containing suitable subliming agent. This work helped in understanding the effect of formulation processing variables especially the subliming agent on the drug release profile. The present study demonstrated potentials for rapid absorption, improved bioavailability, effective therapy and patient compliance.

M3 - Article

VL - 1

SP - 210

EP - 214

JO - International Journal of PharmTech Research

JF - International Journal of PharmTech Research

SN - 0974-4304

IS - 2

ER -