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

Diserahkan: 22 Mac 2015/Diterima: 19 Ogos 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

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*Pengarang untuk surat-menyurat; email: lcteh86@gmail.com