FORMULATION OF CHLORPHENIRAMINE MALEATE TABLETS USING CO-PROCESSED EXCIPIENT AS A FILLER AND BINDER

Yandi Syukri, Romdhonah Romdhonah, Anisa Nur Fazzri, Rio Fandi Sholehuddin, Aris Perdana Kusuma

Abstract


Co-Processed Excipient (CPE) is technological innovation for tablet preparation through the direct compression method with a quick and straight forward manufacturing process because it improves the compressibility and flowability. This research aimed to formulate and evaluate of chlorpheniramine maleate tablets using spray dried CPE as filler and binder. The spray dried CPE containing MCC PH 101, and Kollidon K30 was made into tablets through a direct compression method. Meanwhile, Ludipress and Avicel PH 102 were used as filler-binder comparators. All the prepared tablet formulations were then evaluated for weight variation, hardness, friability, disintegration time, content uniformity of active ingredient, and dissolution test. The physical properties of tablets with CPE as a filler and binder produced an average weight of 151.65 1.53 mg, 5.92 0.38 kg of hardness, 0.06 0.051% friability, 520.00 2.00 seconds of disintegration time, and 99.24 0.15% content uniformity of active ingredient. The comparators indicated better disintegration time than CPE (p<0.05), while the dissolution test showed that more than 80% (Q) of the amount of active ingredient was dissolved in 30 minutes. CPE could be successfully used to prepare tablet dosage form, and the tablets had fulfilled the standards of pharmacopoeia.


Keywords



Full Text:

PDF

References


Aljaberi, A., Ardakani, A., Khdair, A., Abdel-Rahim, S.A., Meqdadi, E., Ayyash, M., Alobaidi, G.M., and Al-Zoubi, N., 2013. Tableting functionality evaluation of Prosolv Easytab in comparison to physical mixtures of its individual components. J Drug Sci. Tech., 23, 499504.

Al-Zoubi, N., Odeh, F., and Nikolakakis, I., 2017. Co-spray drying of metformin hydrochloride with polymers to improve compaction behavior. Powder Technol., 307, 163174.

Anonim, 2014. Farmakope Indonesia, V. ed. Departemen Kesehatan RI, Jakarta.

Anonim, 1995. Farmakope Indonesia, IV. ed. Ministry of Health Republic of Indonesia, Jakarta.

Anonim, 1979. Farmakope Indonesia, III. ed. Departemen Kesehatan RI, Jakarta.

Dave, V., Yadav, R.B., Ahuja, R., and Yadav, S., 2017. Formulation design and optimization of novel fast dissolving tablet of chlorpheniramine maleate by using lyophilization techniques. Bull. Fac. Pharm. Cairo Univ. 55, 3139.

Dong, Q., Zhou, M., Lin, X., Shen, L., and Feng, Y., 2018. Differences in fundamental and functional properties of HPMC co-processed fillers prepared by fluid-bed coating and spray drying. Eur. J. Pharm. Sci., 119, 147158.

Drakovi?, M., Djuri, J., Ibri?, S., and Paroj?i?, J., 2018. Functionality and performance evaluation of directly compressible co-processed excipients based on dynamic compaction analysis and percolation theory. Powder Technol., 326, 292301.

Eraga, S.O., Arhewoh, M.I., Uhumwangho, M.U., and Iwuagwu, M.A., 2015. Characterisation of a novel, multifunctional, co-processed excipient and its effect on release profile of paracetamol from tablets prepared by direct compression. Asian Pac. J. Trop. Biomed., 5, 768772.

Gonnissen, Y., Gonalves, S.I.V, De Geest, B.G., Remon, J.P., and Vervaet, C., 2008. Process design applied to optimise a directly compressible powder produced via a continuous manufacturing process. Eur. J. Pharm. Biopharm., 68, 760770.

Jacob, S., Shirwaikar, A.A., Joseph, A., and Srinivasan, K.K., 2007. Novel co-processed excipients of mannitol and microcrystalline cellulose for preparing fast dissolving tablets of glipizide. Indian J. Pharm. Sci., 69, 633.

Komersov, A., Locha?, V., Myslkov, K., Mukov, J., and Barto, M., 2016. Formulation and dissolution kinetics study of hydrophilic matrix tablets with tramadol hydrochloride and different co-processed dry binders. Eur. J. Pharm. Sci., 95, 3645.

Kusuma, A.P., Syukri, Y., Sholehuddin, R.F., Fazzri, A.N., Romdhonah, and Hakim, R.B.F., 2017. Optimization of Microcrystalline Cellulose PH 101, Lactose, and Kollidon K 30 To Obtain Co-Processed Excipient Through Spray Drying. Int. J. Drug Deliv. Technol., 7, 8388.

Lashkarbolooki, M., Hezave, A.Z., Rahnama, Y., Rajaei, H., and Esmaeilzadeh, F., 2013. Solubility of chlorpheniramine maleate in supercritical carbon dioxide. J. Supercrit. Fluids, 84, 2935.

Mukov, J., Hvov, S., Ondrej?ek, P., Komersov, A., and Locha?, V., 2014. A study of tablets with a co-processed dry binder containing hypromellose and ?-lactose monohydrate. J. Drug Deliv. Sci. Technol., 24, 100104.

Osamura, T., Takeuchi, Y., Onodera, R., Kitamura, M., Takahashi, Y., Tahara, K., and Takeuchi, H., 2016. Characterization of tableting properties measured with a multi-functional compaction instrument for several pharmaceutical excipients and actual tablet formulations. Int. J. Pharm., 510, 195202.

Rojas, J., and Kumar, V., 2011. Comparative evaluation of silicified microcrystalline cellulose II as a direct compression vehicle. Int. J. Pharm., 416, 120128.

Syukri, Y., Fernenda, L., Utami, F.R., Qiftayati, I., Kusuma, A.P., and Istikaharah, R., 2015. Preperation and Characterization of ?-Cyclodextrin Inclusion Complexes Oral Tablets Containing Poorly Water Soluble Glimipiride using Freeze Drying Method. Indones. J. Pharm., 26, 71.

United States Pharmacopeial Convention, 2014. U.S. Pharmacopeia National Formulary, USP 37 NF 32. United States Pharmacopeial, Rockville, USA.

Wang, S., Li, J., Lin, X., Feng, Y., Kou, X., Babu, S., and Panicucci, R., 2015. Novel coprocessed excipients composed of lactose, HPMC, and PVPP for tableting and its application. Int. J. Pharm., 486, 370379.




DOI: https://doi.org/10.24071/jpsc.001717

Article Metrics

Abstract view : 7289 times
PDF view: 3054 times

Refbacks

  • There are currently no refbacks.


Copyright (c) 2019 Jurnal Farmasi Sains dan Komunitas (Journal of Pharmaceutical Sciences and Community)

 

 

 

 

 

 

 

  

Jurnal Farmasi Sains dan Komunitas (Journal of Pharmaceutical Sciences and Community)

Published by Faculty of Pharmacy, Universitas Sanata Dharma Yogyakarta

Creative Commons Licence
This work is licensed under a Creative Commons Attribution 4.0 International License.

JPSC Stats