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Original Research Article
Pharmacokinetic Study of a
Capsule-based Chronomodulated Drug Delivery System of
Salbutamol Sulphate in Rabbits
Mohd Javed Qureshi1, 2,
Javed Ali1, Sanjula Baboota1, Alka
Ahuja1 and Chitneni Mallikarjun3
1
Department of Pharmaceutical
Technology, School of Pharmacy, Taylor’s University,
Lakeside Campus, Selangor Malaysia, 2
Department of Pharmaceutics, Jamia Hamdard (Hamdard
University), New Delhi, India, 3Department of
Pharmaceutical Technology, International Medical
University, Kuala Lumpur, Malaysia.
*For correspondence:
Email:
Mohd.Javed@taylors.edu.my
Received:
9 June 2013
Revised accepted: 4
November 2013
Tropical Journal of
Pharmaceutical Research, January 2014;
13(1):
17-22
http://dx.doi.org/10.4314/tjpr.v13i1.3
Abstract
Purpose: To develop and determine
the in vivo performance of a capsule-based pulsatile
drug delivery system containing salbutamol sulphate
Methods: A controlled
pulsatile release of drug after a programmed 4 h lag
period was achieved from cross-linked gelatin capsule
shells containing salbutamol pellets, and sealed with a
suitable mixture of sodium alginate and ethyl cellulose
as plug. In order to confirm the utility of developed
system for the management of nocturnal asthma, a
crossover study was conducted. six male rabbits were
fasted overnight and divided into two groups comprised
of 3 rabbits each. The individual rabbits were
administered the developed pulsatile capsule and
immediate release salbutamol capsule as reference,
separately. Blood samples were collected from the ear
vein of the animals into heparinized tubes and used to
determine pharmacokinetic parameters, namely, maximum
plasma concentration (Cmax), time to reach
maximum plasma concentration (Tmax), and area
under the plasma concentration - time curve (AUC0-∞)
using a validated HPLC method.
Results: It was observed that drug
release from the optimized time-controlled capsule
stopped for a period of approximately 4.25 h with an
average Cmax and Tmax of 271.54 ±
58.95 ng/ml and 6.00 ± 0.25 h. The AUC0-∞ of
salbutamol after administration of the time-controlled
pulsatile system was 2494.73 ± 525.95 ng h/ml while that
of the immediate-release formulation was 2352.77 ±
432.51 ng h/ml. Using ANOVA at a significant difference
of p < 0.05 (CI 95%), there was no significant
difference for the AUC0-∞ between immediate
release and the pulsatile capsule developed.
Conclusion: The developed system is
capable of releasing salbutamol after a 4 h lag period
and can be considered as promising delivery system for
time-controlled (pulsatile) delivery of the medication
for the management of nocturnal asthma.
Keywords:
pH-controlled release, Lag time, Pulsatile release,
Hydrocolloid plug, Nocturnal asthma.
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