Formulation and Evaluation of Swellable and Floating Gastroretentive Ciprofloxacin Hydrochloride Tablets

Arza, Ramji Anil Kumar; Gonugunta, Chandra Sekhara Rao; Veerareddy, Prabhakar Reddy

doi:10.1208/s12249-009-9200-y

Cited by 81 publications

(40 citation statements)

References 21 publications

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“…The resultant blend was free flowing and further compressed using 12 mm round standard concave punch sets at 500 mg target weight. In the present formulation, sodium bicarbonate was used to generate carbon dioxide to increase buoyancy and crospovidone as swelling agent [27] as well as to increase hydration capacity [28] of tablets. The levels of sodium bicarbonate and crospovidone were fixed at 7% w/w and 10% w/w respectively.…”

Section: Qtpp Of Dpm Gastroretentive Floating Tabletsmentioning

confidence: 99%

Untitled

Shah

2017

AJP

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Introduction: This research focuses on development and optimization of dipyridamole (DPM) gastroretentive (GR) floating matrix tablets through risk-based approach using combination of rate controlling hydrophilic polymers. Materials and Methods: A 3 2 full factorial design was deployed to optimize ratio of polymers and polymer concentration in the formulation. Dissolution studies, Buoyancy studies, swelling index studies, kinetic modelling, drug content, and differential scanning calorimetry studies were performed to effectively assess developed gastroretentive dosage form. Estimation of related substances was also done for optimized formulations to check the stability of dosage form during shelf life. Results and Discussion: Buoyancy studies suggested that concentration of PanExcea™ GR polymer should be at least 25% w/w or more to get better floating and swelling capabilities if used alone as rate controlling polymer. Selection of optimum batches was done using constraintbased graphical optimization technique. The optimum batches exhibited desired extended drug dissolution profile, minimal floating lag time, and total floating time of >12 h. Thermal characterization studies also preclude any drug polymer interaction and change in polymorphic form of drug during manufacturing process. Stability studies indicated optimized formulations are stable under selected packaging configurations. Conclusion: The present research exemplifies successful application of quality by design approach in designing gastroretentive dosage form of DPM. From the present study, it can be concluded that selection of appropriate ratio and concentration of hydrophilic polymers play a pivotal role in matrix integrity, buoyancy, swelling potential as well as drug release profile of GRDDS.

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Section: Qtpp Of Dpm Gastroretentive Floating Tabletsmentioning

confidence: 99%

Untitled

Shah

2017

AJP

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“…The samples were filtered through a 0.45-μm membrane filter and diluted to a suitable concentration. The absorbance of these solutions was measured at 276 nm using a UV-vis spectrophotometer (Shimadzu 1800) (11). The percentage drug release was plotted against time to construct drug release profile for the formulation ( Figure 5).…”

Section: Marketed Floating Tablet Formulation Containing Ciprofloxacimentioning

confidence: 99%

Design and Evaluation of a Novel Bio-Mimicking In Vitro Dissolution Test Apparatus for Floating Drug Delivery Systems

Baldaniya¹,

Saisivam²,

Gohel³

2015

Dissolution Technol.

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The aim of the present study was to design a new biorelevant dissolution test apparatus for evaluating floating drug delivery systems. The gastric fluid secretion rate, volume of gastric fluid present in the stomach, and gastric emptying from the pylorus opening were taken into consideration. The material of construction was borosilicate glass. In vitro dissolution testing of pharmaceutical dosage forms is performed for quality control purposes and to establish in vitro-in vivo correlations (IVIVC). Compendial in vitro dissolution test apparatus are poor predictors of the in vivo performance of a floating drug delivery system (FDDS). The drawbacks associated with compendial and noncompendial dissolution test apparatus were rectified in the present study. A magnetic stir bar provided agitation of the dissolution medium for uniform mixing. The phenomenon of gastric emptying was mimicked by a special assembly attached at the bottom of the glass apparatus. The drug release study was conducted with USP Apparatus 2 (paddle) and an apparatus designed for a commercial floating product. The experiments were run at 37 ± 0.5 °C and a stirring speed of 75 rpm. Analysis of the data was performed by comparing drug release profiles using the similarity factor f 2 as a tool for the assessment of dissolution. In vivo performance was predicted using a convolution technique.

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“…It was observed that all tablet formulations floated longer than 12 h, excluding formulations C-X25 and C-X40 which disintegrated in 2 and 6 hours, respectively. These might be due to the high amount of crospovidone in the formulations and rapid hydration of xanthan gum (15). C-X50 3-4 3.10 ± 0.34 9 ± 0.9 > 12…”

Section: Characterization Of Floating Tabletsmentioning

confidence: 99%

Preparation and in vitro characterization of non-effervescent floating drug delivery system of poorly soluble drug, carvedilol phosphate

et al. 2014

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Preparation and in vitro characterization of non-effervescent floating drug delivery system of poorly soluble drug, carvedilol phosphateThe objective of the study was to enhance the solubility of carvedilol phosphate and to formulate it into non-effervescent floating tablets using swellable polymers. Solid dispersions (SD) of carvedilol were prepared with hydrophilic carriers such as polyvinylpyrrolidone and poloxamer to enhance solubility. Non-effervescent floating tablets were prepared with a combination of optimized solid dispersions and release retarding polymers/swellable polymers such as xanthan gum and polyethylene oxide. Tablets were evaluated for physicochemical properties such as hardness, thickness and buoyancy. SD prepared with the drug to poloxamer ratio of 1:4 by melt granulation showed a higher dissolution rate than all other dispersions. Formulations containing 40 mg of polyethylene oxide (C-P40) and 50 mg xanthan gum (C-X50) were found to be best, with the drug retardation up to 12 hours. Optimized formulations were characterized using FTIR and DSC and no drug and excipient interactions were detected.Keywords: carvedilol phosphate, solid dispersion, non-effervescent, floating tabletsCarvedilol phosphate is a non-selective beta-blocker, prescribed for the treatment of angina, hypertension and congestive heart failure. The reported systemic bioavailability of carvedilol phosphate is 24 % after oral administration (1). The drug reaches peak plasma concentration in 1-2 h with an elimination half-life of 7 to 10 h (1, 2). This drug has a narrow absorption window in the upper gastrointestinal tract and it would benefit from a gastroretentive delivery system. Floating drug delivery system (FDDS) is a gastroretentive system that can be effervescent or non-effervescent. Wu et al. (3) prepared floating sustained release tablets of nimodipine using HPMC and PEG 6000. Prior to formulation of floating tablets, nimodipine was incorporated into a poloxamer-188 solid dispersion, whereafter it was directly compressed into floating tablets. It was observed that by increasing the HPMC and decreasing

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Formulation and Evaluation of Swellable and Floating Gastroretentive Ciprofloxacin Hydrochloride Tablets

Cited by 81 publications

References 21 publications

Untitled

Untitled

Design and Evaluation of a Novel Bio-Mimicking In Vitro Dissolution Test Apparatus for Floating Drug Delivery Systems

Preparation and in vitro characterization of non-effervescent floating drug delivery system of poorly soluble drug, carvedilol phosphate

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