Vol-3, Issue-1, Jan-2012 ISSN: 0976-7908 Surani et al www.pharmasm.com IC Value – 4.01 123 PHARMA SCIENCE MONITOR AN INTERNATIONAL JOURNAL OF PHARMACEUTICAL SCIENCES DESIGN, DEVELOPMENT AND EVALUATION OF THE HYDRODYNAMICALLY BALANCED TABLETS OF CIPROFLOXACIN HYDROCHLORIDE Vijaykumar S. Surani* 1 , Jignesh J. Donga 1 , Sachin Chauhan 1 , Tejas Ghelani 1 , AK Seth 1 ,Nirmal Shah 1 , Sharad Kumar 1 , Yogesh Chand Yadav 1 , Vipin Saini 2 1 Department of Pharmacy, Sumandeep Vidyapeeth, Waghodiya, Vadodara, Gujarat, India 2 MJRP Health Care & Allied Sciences, MJRP University Jaipur (Rajasrhan). ABSTRACT Ciprofloxacin HCl has an absorption window in the stomach and in the upper part of the small intestine. The present investigation concerns the development of hydrodynamically balanced tablets of ciprofloxacin, which are designed to prolong the gastric residence time and thereby increase drug bioavailability after oral administration. Five different batches of tablets were fabricated containing Ciprofloxacin, polymers like HPMC K4M, HPMC K15M and Chitosan, along with gas generating agent sodium bicarbonate. The physicochemical properties of different formulations, their buoyancy lag time, total floatation time and swelling index were evaluated. It was found that the hardness of the tablet will effect the buoyancy characteristic of the dosage form. The in vitro release studies (USP XXIII) indicated that the floating dosage forms containing HPMC K15M showed slower release and the integrity of the device was maintained. The % drug release profile was found in the order of F2 > F3 > F6 > F1 > F5 > F4. The in vitro release data was treated with mathematical equations, and it was concluded that release of ciprofloxacin from the tablet follows Peppas model with non-Fickian diffusion. F2 formulation showed better control of drug release with comparison to marketed product. Finally the results had proven that the gas powered Hydrodynamically Balanced Tablets of ciprofloxacin containing HPMC K15M provides a better option for controlled release action and improved bioavailability. Keywords: Gastric residence; Gas generation; Swelling index; Ciprofloxacin. INTRODUCTION Oral drug delivery is the most widely utilized route of administration among all the routes that have been explored for systemic delivery of drugs via pharmaceutical products of different dosage form. Oral route is considered most natural, uncomplicated, convenient and safe due to its ease of administration, patient acceptance, and cost- effective manufacturing process. [1,2]
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Vol-3, Issue-1, Jan-2012 ISSN: 0976-7908 Surani et al
www.pharmasm.com IC Value – 4.01 123
PHARMA SCIENCE MONITOR AN INTERNATIONAL JOURNAL OF PHARMACEUTICAL SCIENCES
DESIGN, DEVELOPMENT AND EVALUATION OF THE
HYDRODYNAMICALLY BALANCED TABLETS OF CIPROFLOXACIN
HYDROCHLORIDE
Vijaykumar S. Surani*1, Jignesh J. Donga1, Sachin Chauhan1, Tejas Ghelani1, AK
1Department of Pharmacy, Sumandeep Vidyapeeth, Waghodiya, Vadodara, Gujarat, India 2MJRP Health Care & Allied Sciences, MJRP University Jaipur (Rajasrhan).
ABSTRACT Ciprofloxacin HCl has an absorption window in the stomach and in the upper part of the small intestine. The present investigation concerns the development of hydrodynamically balanced tablets of ciprofloxacin, which are designed to prolong the gastric residence time and thereby increase drug bioavailability after oral administration. Five different batches of tablets were fabricated containing Ciprofloxacin, polymers like HPMC K4M, HPMC K15M and Chitosan, along with gas generating agent sodium bicarbonate. The physicochemical properties of different formulations, their buoyancy lag time, total floatation time and swelling index were evaluated. It was found that the hardness of the tablet will effect the buoyancy characteristic of the dosage form. The in vitro release studies (USP XXIII) indicated that the floating dosage forms containing HPMC K15M showed slower release and the integrity of the device was maintained. The % drug release profile was found in the order of F2 > F3 > F6 > F1 > F5 > F4. The in vitro release data was treated with mathematical equations, and it was concluded that release of ciprofloxacin from the tablet follows Peppas model with non-Fickian diffusion. F2 formulation showed better control of drug release with comparison to marketed product. Finally the results had proven that the gas powered Hydrodynamically Balanced Tablets of ciprofloxacin containing HPMC K15M provides a better option for controlled release action and improved bioavailability. Keywords: Gastric residence; Gas generation; Swelling index; Ciprofloxacin. INTRODUCTION
Oral drug delivery is the most widely utilized route of administration among all
the routes that have been explored for systemic delivery of drugs via pharmaceutical
products of different dosage form. Oral route is considered most natural, uncomplicated,
convenient and safe due to its ease of administration, patient acceptance, and cost-
effective manufacturing process.[1,2]
Vol-3, Issue-1, Jan-2012 ISSN: 0976-7908 Surani et al
www.pharmasm.com IC Value – 4.01 124
Controlled drug delivery systems have been developed which are capable of
controlling the rate of drug delivery, sustaining the duration of therapeutic activity and/or
targeting the delivery of drug to a tissue.[3,4,5]
One of the most feasible approaches for achieving a prolonged and predictable
drug delivery in the GI tract is to control the gastric residence time (GRT), i.e. gastro
retentive dosage form (GRDF or GRDS).[6]
GRDFs extend significantly the period of time over which the drugs may be
released. They not only prolong dosing intervals, but also increase patient compliance
beyond the level of existing controlled release dosage form.[7,8]
To formulate a successful gastro-retentive drug delivery system, several
techniques are currently used such as hydrodynamically balanced systems (HBS)/
floating drug delivery system[9] , low-density systems[10,11,12], raft systems incorporating
alginate gels[13,14], bioadhesive or mucoadhesive systems[15], high density systems[16],
superporous hydrogels [17] and magnetic systems.[18,19]
MATERIALS AND METHODS
Ciprofloxacin were gift samples from (Zydus cadila Ltd), HPMC K4M and
HPMC K15M (Colorcon Asia Pvt. Ltd.), Chitosan (Central Institute of Fisheries
Technology, Cochin), Sodium bicarbonate (Poona Chemical Laboratory), Lactose