Oral osmotically driven systems: 30 years of development and clinical use

Malaterre, Vincent; Ogorka, Joerg; Loggia, Nicoletta; Gurny, Robert

doi:10.1016/j.ejpb.2009.07.002

Cited by 112 publications

(49 citation statements)

References 119 publications

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“…Thus, PEG 400 was selected as water-soluble pore forming agent. All other excipients chosen were based on practical experience and literature review (32,33). The compatibility of TAP and other selected excipients was confirmed from the results of DSC study.…”

Section: Discussionmentioning

confidence: 99%

Development and Evaluation of a Once-Daily Controlled Porosity Osmotic Pump of Tapentadol Hydrochloride

2015

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Abstract. The present study aimed to prepare, optimize, and evaluate Tapentadol hydrochloride controlled porosity osmotic pump (CPOP) and to achieve the drug release at nearly zero-order. The CPOP was prepared by the coating of polymers (Eudragit RSPO and RLPO) on a directly compressed core tablet. A Box-behnken experimental design was applied to optimize the parameters for CPOP. The optimized batch was characterized for in vitro drug release study, effect of pH, osmolarity and agitation intensity, and surface morphology and stability study. In vivo pharmacokinetic studies were performed on New Zealand white rabbits for CPOP and marketed tablet. All the batches showed a drug release ranging from 29.87 to 56.92% after 12 h; and from 59.64 to 99.96% after 24 h. There was no change in the drug release pattern at different pH and agitation intensities. The drug release was found to decrease with increasing osmolarity of dissolution media.An in vivo study showed a higher mean residence time, area under the curve, and biological half-life (T 1/2 ) than the marketed tablet with low rate of elimination (Ke) and a 2.35-fold increase in relative bioavailability. The result showed that the amounts of sodium chloride and PEG 400 were contributing positively while the number of coats was negatively affecting the drug release. The drug release was found to be independent of physiological conditions. The stability testing showed that the prepared CPOP was stable for 3 months at accelerated conditions. The prepared CPOP was found to deliver Tapentadol hydrochloride at zero-order for up to 24 h.

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Section: Discussionmentioning

confidence: 99%

Development and Evaluation of a Once-Daily Controlled Porosity Osmotic Pump of Tapentadol Hydrochloride

2015

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“…Drug release from these systems is independent of pH and hydrodynamic conditions of the GIT to a large extent, and the release characteristics can be adjusted easily by formulation parameters [9][10]. The MOT system is simple to be prepared as exempting from push layer and simplifying in the orifice drilling compared with the pushpull osmotic tablet and used in the drug controlled delivery field, especially suitable for water-insoluble drugs [11].…”

Section: Introductionmentioning

confidence: 99%

Development and Evaluation of Monolithic Osmotic Tablet of Ketoprofen: Using Solid Dispersion Technique

Kaushik

Pathak

2016

Int J Pharm Pharm Sci

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Objective: The aim of the present study was to develop and evaluate the monolithic osmotic tablet (MOT) composed of the solid dispersion of ketoprofen (KETO), a poorly water-soluble drug. Solid dispersion technique is generally used for immediate release, as this maximizes the amount of drug absorbed. Sustained release may be obtained by combining solid dispersion technique with MOT so as to increase the therapy efficacy and patient compliance.Methods: Solid dispersion of KETO was prepared by using solvent melt method with polyethylene glycol (PEG) 6000, a hydrophilic carrier. The ratio of KETO to PEG 6000 were 1:1, 1:3 and 1:5 (%w/w). These solid dispersions were characterized by differential scanning calorimetry (DSC), Thermogravimetric analysis (TGA) and powder X-ray diffraction (PXRD) to ascertain whether there were any physicochemical interactions between drug and carrier.The tablet core was prepared by using Polyox N80 (a suspending agent), sodium chloride (an osmotic agent), a solid dispersion consisting of PEG 6000 and KETO followed by a coating of cellulose acetate to make the monolithic osmotic tablet. Results:The results of DSC and PXRD indicated that the drug was in the amorphous state in solid dispersion when PEG 6000 was used as a carrier. The dissolution rate of the solid dispersion was much faster than those for the corresponding physical mixture and pure drug. The optimized MOT formulations were able to deliver KETO at the constant zero order release, above 95% in vitro, independent to environmental media and stirring rate. The release rate of KETO in the MOT is controlled by osmotic pressure, suspending agent and drug solubility in solid dispersion. Conclusion:The monolithic osmotic tablet containing solid dispersion has great potential in the controlled delivery of ketoprofen, a water-insoluble drug.

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“…The main clinical benefits of these systems are improving treatment tolerability and patient compliance, especially for drugs with narrow therapeutic index. However, access to the relevant technologies has been restricted due to perceived and real manufacturing constraints and the patent landscape (2)(3)(4)(5)(6)(7)(8)(9)(10)(11).…”

Section: Introductionmentioning

confidence: 99%

Investigation of Critical Core Formulation and Process Parameters for Osmotic Pump Oral Drug Delivery

et al. 2013

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Abstract. Push-pull osmotic pump (PPOP) tablets of a practically insoluble model drug were developed and the effect of various formulation and process parameters on tablet performance was evaluated in order to identify critical factors. The formulation factors such as the viscosity grade of polyethylene oxide as the primary polymer as well as the level and location of osmogen within the bilayer tablets led to a difference in performance of osmotic tablets and hence should be critically evaluated in the design of such dosage forms. Modification of granulation process, i.e., the granulating liquid composition or drying method of granules, did not impact the drug release from the osmotic tablets at the evaluated scale of this study. The influence of varying dose and aqueous solubility of other model drugs (i.e., theophylline, acetaminophen, and verapamil HCl) on the developed PPOP template was also investigated. Results showed that irrespective of the perceived complexity of development and manufacturing of osmotic pumps, the osmotic tablets in this study demonstrated a robust and yet flexible platform in accommodating different types of drug candidates, regardless of solubility, for the dose levels below 25% w/w of the pull layer formulation.

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Oral osmotically driven systems: 30 years of development and clinical use

Cited by 112 publications

References 119 publications

Development and Evaluation of a Once-Daily Controlled Porosity Osmotic Pump of Tapentadol Hydrochloride

Development and Evaluation of a Once-Daily Controlled Porosity Osmotic Pump of Tapentadol Hydrochloride

Development and Evaluation of Monolithic Osmotic Tablet of Ketoprofen: Using Solid Dispersion Technique

Investigation of Critical Core Formulation and Process Parameters for Osmotic Pump Oral Drug Delivery

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