Development and Evaluation Controlled Release Diclofenac Sodium Matrix Tablets
Development and Evaluation Controlled Release Diclofenac Sodium Matrix Tablets
No Thumbnail Available
Date
2015-04-06
Authors
Ahmed, Abdalla
Journal Title
Journal ISSN
Volume Title
Publisher
University of Khartoum
Abstract
In vitro release profiles were studied for the matrix controlled
release Diclofenac sodium tablets (MT20, MT33, MT34) in comparison
with Voltaren retard (V.R) a well known marketed Diclofenac sodium
controlled release tablets from Novartis® (Switzerland). Percentage
release of Diclofenac sodium was studied in gradient pHS (1.2, 2.1, 4.2,
5.5, 6.5, 6.7, & 7.2) in accordance with gastric pHS, which are varying
from pH one to eight. The study included the release profiles and
evaluated the kinetics of diffusion and diffusion exponents.
Analysis of new controlled release oral drug delivery systems using, C8
(Eurosphere-100 (5 µm) 4.6 mm ID x 250 mm) and C18 (Eurosphere-100
(5 µm) 4 mm ID x 100 mm) columns was carried out. The mobile phase
was phosphate buffer/methanol. Spectrophotometric detection was at 272
nm. Percentages of content for the different matrices were evaluated.
Based on t-test no significantdifference was found between
content measurements using C8 and C18 columns at p′-value of 0.05.
(Observed t-value was 0.062 compared to the theoretical value of 2.15.
Content analysis showed good precision and accuracy with C8 rather than
C18.
In vivo performance and bio-equivalence of controlled release
matrix tablets (MT33) containing gum Arabic and Guar gum was
compared to a standard control drug Voltaren retard in healthy male
volunteers.
The study design was randomized cross-over study. Blood samples
were collected at pre-determined periods, up to 12 hours and one sample
was taken after 24 hours.
High performance liquid chromatographic (HPLC) analysis was
done for both sample and control. Parameters such as Cmax,Tmax, AUC0-24,
iii
Keland MRT0-24. AUMC
0-t, AUMC
0-∞were obtained. The bioequivalence of both formulationswas evaluated which showed no
difference in prolonged action in vivo performance between controlled
matrix tablets (MT33 ) containing gum Arabic and guar gum compared
to a standard control drug ; Voltaren retard in healthy volunteers.
Accelerated stability study for six months was performed for
controlled release matrix tablets (MT20, MT33, MT34, MT33p, MT34p)
containing natural gums (gum Arabic, guar gum), semi-synthetic gum
(Xanthan gum), Eudragit L100 (methacrylic acid and methyl
methacrylate), and Hydroxypropylmethylcellulose.
Microbiological tests for matrices were evaluated by comparing
preserved and non preserved tablets. Content was found to be 90-105% in
all the five matrix formulae. Applying out of trend stability rules (OOT),
the best formula was MT33 which contain guar gum 15% and gum
Arabic 15%. No changes in physical appearance and organoleptic
properties were observed. No microbiological growth (bacteria or fungi)
was observed in both preserved and non-preserved controlled release
formulae.
Description
148 Pages
Keywords
Diclofenac sodium,healthy male,blood