 |
 |
 |
 |
 |
 |
Sains Malaysiana 46(4)(2017):
597–604 http://dx.doi.org/10.17576/jsm-2017-4604-12
Development of Diabecine™ Tablet and Confirmation
of Its Physical Properties and Pharmaceutical Safety Analysis (Pembangunan Tablet Diabecine™ dan Pengesahan
Sifat Fizikal dan Analisis Keselamatan Farmaseutik) TEH LIAM
CHEE1*,
FADZILAH
ADIBAH
ABDUL
MAJID2
& MOHD CAIRUL IQBAL3 1Department of Bioprocess Engineering,
Faculty of Chemical Engineering, Universiti Teknologi Malaysia,
81310 UTM Johor Bahru, Johor Darul Takzim, Malaysia 2Institute of Bioproduct Development
(IBD), Universiti Teknologi Malaysia 81310 UTM Johor Bahru, Johor Darul
Takzim, Malaysia 3Faculty of Pharmacy, Universiti
Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz 50300 Kuala Lumpur, Federal Territory,
Malaysia Received: 22 March 2015/Accepted:
19 August 2016 ABSTRACT Herbal medicine is usually
made using dry powdered herbs in the form of capsule. Capsule form
herbal supplement suffers lower shelf life as compared to compact
herbal powder in tablet form. In this study, Diabecine™, a blend
of herbal medicine traditionally used as herbal supplement for diabetic
patients was selected and transformed into a compressed tablet.
Direct compression method and minimal usage of excipients were the
aims of this study. By using direct compression, the blend of 40%
fine powder herbs and 60% of excipients performed the best and fulfill
the pharmaceutical standard. The safety data of microbial and heavy
metal testing obtained met the safety requirements for herbal supplement
category under the National Pharmaceutical Control Bureau of Malaysia.
In conclusion, the tablet formulation of Diabecine™ is suitable to be manufactured
by using direct compression method. This research implicates the
possibility of producing tablets with high dose of herbal powder
by direct compression method. Keywords: Direct compression;
FTIR; herbal supplement; impurity; tablet characteristic
ABSTRAK Ubat herba biasanya diperbuat
daripada serbuk kering herba dalam bentuk kapsul. Suplemen herba
dalam bentuk kapsul mempunyai jangka hayat yang lebih rendah berbanding
dengan serbuk herba yang dipadat dalam bentuk tablet. Dalam kajian
ini, Diabecine™, satu campuran ubat herba yang digunakan secara
tradisi sebagai suplemen herba untuk pesakit kencing manis telah
dipilih dan diubah menjadi mampatan tablet. Kaedah pemampatan terus
dan penggunaan eksipien yang minimum adalah matlamat kajian ini.
Dengan menggunakan pemampatan terus, campuran mencapai prestasi
yang terbaik dan memenuhi piawaian farmaseutik. Data keselamatan
ujian mikrob dan logam berat yang diperoleh telah memenuhi keperluan
keselamatan bagi kategori suplemen herba di bawah Biro Pengawalan
Farmaseutik Kebangsaan Malaysia. Kesimpulannya, formulasi tablet
Diabecine™ adalah
sesuai untuk dimampatkan dengan menggunakan kaedah pemampatan terus.
Kajian ini mengimplikasikan kemungkinan untuk menghasilkan tablet
dengan dos serbuk herba yang tinggi dengan kaedah pemampatan terus.
Kata kunci: Cemaran; ciri tablet; FTIR;
pemampatan terus; suplemen herba REFERENCES 2006.
The International Pharmacopoeia: World Health Organization.
2009.
<1217> Tablet Breaking Force. In USP32-NF27. 2012.
British Pharmacopoeia 2013: Great Britain. Her Majesty’s
Stationery Office. 2013.
Drug Registration Guidance Document (DRGD), edited by Director
of Pharmaceutical Services. 1st ed. Malaysia: National Pharmaceutical
Control Bureau. Guidance Document. Adetunji,
O.A., Odeniyi, M.A. & Itiola, O.A. 2006. Compression, mechanical
and release properties of chloroquine phosphate tablets containing
corn and trifoliate yam starches as binders. Tropical Journal
of Pharmaceutical Research 5(2): 589-596. Bandaranayake,
W.M. 2006. Quality control, screening, toxicity, and regulation
of herbal drugs. In Modern Phytomedicine. New York: Wiley-VCH Verlag GmbH
& Co. KGaA. pp. 25-57. Banker, G.S., Siepmann, J. &
Rhodes, C. 2002. Modern Pharmaceutics. 4th ed. New York:
Taylor & Francis. Carter, J.C. 2006. The role of disintegrants
in solid oral dosage manufacturing. Carter Pharmaceutical Consulting,
Inc. Accessed on 27 Jan. http://www. carterpharmaceuticalconsulting.com/articles/The-role-of-disintergrants.html.
Chaves, J.S., da Costa, F.B., de
Freitas, L.A.P. 2009. Development of enteric coated tablets from
spray dried extract of feverfew (Tanacetum parthenium L.).
Brazilian Journal of Pharmaceutical Sciences 45(3): 573-584.
Chen, J.B., Zhou Qun & Sun,
S-Q. 2010. Rapid quality control of the traditional remedy “Chinese
Goldthread” by FT-IR spectrometry. Application Note. Waltham:
PerkinElmer Inc. Cragg, G.M. & Newman, D.J. 2005.
International collaboration in drug discovery and development from
natural sources. Pure and Applied Chemistry 77(11): 1923-1942.
Davydova, N. 2008. <2040>
Disintegration and Dissolution of Dietary Supplements In United
States Pharmacopeia- National Formulary. Twinbrook Parkway,
Rockville: The United States Pharmacopeial Convention. Deepak, P., Abhishek, J., Rakesh,
K.J. & Hariharanand, S. 2011. Formulation and evaluation of
pioglitazone hydrochloride matrix tablet containing aloe barbadensis
miller mucilage natural antidiabetic agent. International Journal
of Drug Discovery and Herbal Research July-September 1(3): 157-
163. Ganapaty, S., Ramaiah, M., Yasaswini,
K. & Babu, P.M. 2013. In vitro, in vivo standardization,
formulation and evaluation of directly compressed polyherbal hepatoprotective
tablets. Int. J. Res. Ayurveda Pharm. 4(5): 769-780. Gbenga, B.L. & Olabanji, O.
2013. Formulation and evaluation of a new herbal tablet from the
stem bark of Enatia chlorantha. International Journal
of Pharmaceutical Sciences Review and Research 18(1): 170-175.
Ghiware, N.B., Gattani, S.G., Chalikwar,
S.S. 2010. Design, development and evaluation of oral herbal formulations
of Piper nigrum and Nyctanthes arbortristis. International
Journal of PharmTech Research 2(1): 171-176. Gibson, M. 2001. Pharmaceutical
Preformulation and Formulation: A Practical Guide from Candidate
Drug Selection to Commercial Dosage Form. New York: Taylor &
Francis. Gilhotra, U.K., Govind Mohan &
Christina, A.J.M. 2013. Antilithiatic activity of poly-herbal formulation
tablets by in-vitro method. Journal of Applied Pharmaceutical
Science 3(5): 43-48. Ibezim, E.C., Attama, A.A., Obitte,
N.C., Onyishi, V.I. & Brown, S.A. 2008. In vitro prediction
of in vivo bioavailability and bioequivalence of brands of
metronidazole tablets in Eastern Nigerian drug market. Scientific
Research and Essay 3(11): 552-558. Jain, D., Sofiya, V., Shashi, B.S.,
Alok, P.J., Prakash, J. & Priyanka, Y. 2010. Formulation and
evaluation of gastroretentive tablets of Furosemide (Evaluation
based on drug release kinetics and factorial designs). Journal
of Chemical and Pharmaceutical Research 2(4): 935-978. Joshi, D. 2012. FTIR spectroscopy:
Herbal drugs and fingerprints. In Herbal Drugs and Fingerprints.
Springer India. pp. 121- 146. Kim, H.B. 2009. Handbook of Stability
Testing in Pharmaceutical Development: Regulations, Methodologies,
and Best Practices. New York: Springer-Verlag. Majekodunmi, S.O. & Odeku, O.A.
2009. Effects of interacting variables on the formulation of Alstonia
boonei De Wild (Apocynaceae) tablets. Acta Pharmaceutica Sciencia
51: 141-148. Nair, L.D., Sar, S.K., Arora, A.
& Mahapatra, D. 2013. Fourier transform infrared spectroscopy
analysis of few medicinal plants of Chhattisgarh, India. Journal
of Advanced Pharmacy Education & Research 3(3): 196-200.
Ning, Y-C. 2011. Interpretation
of infrared spectra. In Interpretation of Organic Spectra.
Singapore: John Wiley & Sons (Asia) Pte Ltd. pp. 129-146. Odeku, O.A. 2008. Tablet Evaluation
Tests. Pharmpedia. Ramaiah, M., Chakravathi, G. &
Yasaswini, K. 2013. In vitro biological standardization,
formulation and evaluation of directly compressed polyherbal anthelmintic
tablets. Pharmacognosy Journal 5(3): 130-134. doi: http://dx.doi.
org/10.1016/j.phcgj.2013.04.004. Rowe, R.C., Sheskey, P.J. &
Quinn, M.E. 2009. Handbook of Pharmaceutical Excipients.
6th ed. London: Pharmaceutical Press. Savarikar, S.S., Barbhind, M.M.,
Halde, U.K. & Kulkarni, A.P. 2011. Pharmaceutical and analytical
evaluation of triphalaguggulkalpa tablets. J. Ayurveda Integr.
Med. 2(1): 21-25. doi: 10.4103/0975-9476.78187. Yuan, X., Koh, H.L. & Chui,
W.K. 2009. The analysis of heavy metals in Chinese herbal medicine
by flow injection-mercury hydride system and graphite furnace atomic
absorption spectrometry. Phytochem. Anal. 20(4): 293-297.
doi: 10.1002/ pca.1126. *Corresponding author;
email: lcteh86@gmail.com
|
|||
|
