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Original Research Article
Formulation and Evaluation
of pH-Responsive Mini-Tablets for Ileo-Colonic Targeted
Drug Delivery
Mohd Abdul Hadi1*,
NG Raghavendra Rao2 and A Srinivasa Rao3
1Department of
Pharmaceutics, Bhaskar Pharmacy College (JB Group of
Educational Institutions), Yenkapally (V), Moinabad (M),
R.R.District, Hyderabad-500075, 2Jyothishmathi
Institute of Pharmaceutical Science, LMD colony,
Karimnagar -505481, 3Bhaskar Pharmacy College
(JB Group of Educational Institutions), Yenkapally (V),
Moinabad (M), R.R.District, Hyderabad-500075, Andhra
Pradesh, India
*For correspondence:
Email:
hadi.lcp@gmail.com; Tel:
91-9949444787
Tropical
Journal of Pharmaceutical Research, July 2014;
13(7): 1021-1029
http://dx.doi.org/10.4314/tjpr.v13i7.3
Abstract
Purpose: To
formulate and evaluate a novel pH-responsive mini-tablet
for ileo-colonic targeted delivery of naproxen in
chronotherapeutic treatment of rheumatoid arthritis.
Methods:
Core mini-tablets were prepared by direct compression
method. These prepared core mini-tablets were then
coated with enteric coating polymers, i.e., Eudragit
L100 and Eudragit S100 in different ratios and
concentrations and filled into an empty hydroxypropyl
methylcellulose (HPMC) capsule. Fourier transform
infrared spectroscopy (FTIR) and diffraction scanning
calorimetry (DSC) studies on the pure drug and its
combination with polymers were performed to assess
compatibility. The formulations were also characterized
for drug content, in-vitro drug release and stability.
Results:
FTIR and DSC data show that there was no interaction
between the drug and the polymers. All the
physicochemical properties of the core mini-tablets were
within acceptable limits. Drug content was 99.42 ± 0.15
%. Optimized formulation F12 released drug after a lag
time of 5.02 ± 0.4 h, with 99.40 ± 0.4 % of the drug
released at the end of 8 h. It was also stable for a
period of 6 months based on International Conference on
Harmonization ICH guidelines.
Conclusion: A novel pH-responsive mini-tablet
formulation of naproxen has been successfully developed
for the chronotherapeutic treatment of rheumatoid
arthritis
Keywords: Ileo-colonic targeted delivery, Naproxen,
Mini-tablets, Hydroxypropyl methylcellulose ,
Chronotherapeutic, Enteric coat, Rheumatoid arthritis |
