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Journal ArticleDOI

Bilayer tablets of Paliperidone for Extended release osmotic drug delivery

01 Nov 2017-Vol. 263, Iss: 2, pp 022020
TL;DR: In this paper, the formulation of paliperidone bilayer tablet core and coating should meet in vitro performance of trilayered Innovator sample Invega, and the optimization of formulation and process was conducted by comparing different in vitro release behaviours of Paliperidine.
Abstract: The purpose of this study is to develop and optimize the formulation of paliperidone bilayer tablet core and coating which should meet in vitro performance of trilayered Innovator sample Invega. Optimization of core formulations prepared by different ratio of polyox grades and optimization of coating of (i) sub-coating build-up with hydroxy ethyl cellulose (HEC) and (ii).enteric coating build-up with cellulose acetate (CA). Some important influence factors such as different core tablet compositions and different coating solution ingredients involved in the formulation procedure were investigated. The optimization of formulation and process was conducted by comparing different in vitro release behaviours of Paliperidone. In vitro dissolution studies of Innovator sample (Invega) with formulations of different release rate which ever close release pattern during the whole 24 h test is finalized.
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Journal ArticleDOI
01 Aug 2022-Polymers
TL;DR: In this article , a brief review on film coating in solid dosage form, which includes tablets, with a focus on the polymers and processes used in the coating process is presented.
Abstract: Coating the solid dosage form, such as tablets, is considered common, but it is a critical process that provides different characteristics to tablets. It increases the value of solid dosage form, administered orally, and thus meets diverse clinical requirements. As tablet coating is a process driven by technology, it relies on advancements in coating techniques, equipment used for the coating process, evaluation of coated tablets, and coated material used. Although different techniques were employed for coating purposes, which may be based on the use of solvents or solvent-free, each of the methods used has its advantages and disadvantages, and the techniques need continued modification too. During the process of film coating, several inter-and intra-batch uniformity of coated material on the tablets is considered a critical point that ensures the worth of the final product, particularly for those drugs that contain an active medicament in the coating layer. Meanwhile, computational modeling and experimental evaluation were actively used to predict the impact of the operational parameters on the final product quality and optimize the variables in tablet coating. The efforts produced by computational modeling or experimental evaluation not only save cost in optimizing the coating process but also saves time. This review delivers a brief review on film coating in solid dosage form, which includes tablets, with a focus on the polymers and processes used in the coating. At the end, some pharmaceutical applications were also discussed.

6 citations

Book ChapterDOI
01 Jan 2023
TL;DR: In this paper , the authors provide an overview of nanotechnology and nanomaterials with regard to varied therapeutic and health-care applications, including smart coatings, which hold predefined properties that make them sense and react to the environment.
Abstract: Smart coatings are special films that hold predefined properties that make them sense and react to the environment and other external stimulants. Special coating has been formulated based on graphene, which exhibits both antibacterial and antiviral properties simultaneously. In recent days, medical complications and expenses are the growing issues due to the biocontamination of medical devices and implants. Advances in nanotechnology and biological sciences made it possible to design smart coatings for decreasing infections. The antibacterial coating is an important tactic and an approach to prevent biofilm formation and bacterial colonization. Recent advances in the field of nanotechnology have shown great potential to overcome life-threatening viral diseases by developing novel broad-spectrum nanotherapeutic platforms to combat viral infections. Some of the nanomaterials have innate toxicity that has a characteristic to destroy the virus directly. This chapter provides an overview of nanotechnology and nanomaterials with regard to varied therapeutic and health-care applications.
Journal ArticleDOI
TL;DR: In this paper , the Quantitative Carbon-13 Nuclear Magnetic Resonance (q13CNMR) spectroscopy method was used to determine the concentration of cellulose acetate (CA) in the microspheres of osmotic-controlled-release oral delivery system (OROS) formulations.
References
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Journal ArticleDOI
TL;DR: Drug delivery using the various OROS products can result in an improved safety profile, stable drug concentrations, uniform drug effects, and reduced dosing frequency, which can enhance patient compliance and convenience, thereby ensuring efficacy and improving patient outcomes.
Abstract: Background: The osmotic-controlled release oral delivery system, OROS, is an advanced drug delivery technology that uses osmotic pressure as the driving force to deliver pharmacotherapy, usually once-daily, in several therapeutic areas.Objective: The purpose of this review is to discuss the evolution of OROS technology and examine the many therapeutic areas where OROS products are being used.Methods: A search of Medline and EMBASE were performed using the keywords ‘OROS’ and ‘osmotic delivery’ for the period January 1990 to June 2005. Data were also obtained from the manufacturers’ websites and associated publications.Results: OROS technology has evolved over the last 30 years, resulting in four systems: the elementary osmotic pump; the two-layer osmotic push–pull tablet; the advanced longitudinally compressed tablet multilayer formulation; and, the L-OROS system. OROS technology is employed for drug delivery in many therapeutic areas including: cardiovascular medicine, endocrinology, urology, and...

189 citations

Journal ArticleDOI
TL;DR: Overall, oral osmotically driven systems appear to be a promising technology for product life-cycle strategies.

126 citations

28 Feb 2017
TL;DR: The basic goal of sustained release is provide promising way to decrease the side effect of drug by preventing the fluctuation of the therapeutic concentration of the drug in the body and increase patient compliance by reducing frequency of dose.
Abstract: The term “sustained release” is known to have existed in the medical and pharmaceutical literature for many decades. It has been constantly used to describe a pharmaceutical dosage form formulated to retard the release of therapeutic agent such that its appearance in the systemic circulation is delayed and/or prolonged and its plasma profile is sustained in duration. Presently pharmaceutical industries are focusing on development of sustained release formulations due to its inherent boons. Sustained release dosage forms are designed to release a drug at a predetermined rate by maintaining a constant drug level for a specific period of time with minimum side effects. The basic rationale of sustained release drug delivery system optimizes the biopharmaceutical, pharmacokinetic and pharmacodynamics properties of a drug in such a way that its utility is maximized, side-effects are reduced and cure of the disease is achieved. There are several advantages of sustained release (matrix) drug delivery over conventional dosage forms like improved patient compliance due to less frequent drug administration, reduction of fluctuation in steady-state drug levels, maximum utilisation of the drug, increased safety margin of potent drug, reduction in healthcare costs through improved therapy and shorter treatment period. The basic goal of sustained release is provide promising way to decrease the side effect of drug by preventing the fluctuation of the therapeutic concentration of the drug in the body and increase patient compliance by reducing frequency of dose. Keywords Sustained-release, Matrix tablet, Patient compliance.

64 citations

Journal ArticleDOI
TL;DR: Paliperidone ER improved psychotic and affective symptoms both as monotherapy and as an adjunct to MS/AD.
Abstract: This 6-week, double-blind, placebo-controlled study evaluated paliperidone extended-release (ER) as both monotherapy and adjunctive therapy to mood stabilizers and/or antidepressants (MS/ADs) for schizoaffective disorder. Included subjects had a schizoaffective disorder diagnosis; a Positive

51 citations

Journal ArticleDOI
TL;DR: Overall, paliperidone ER was effective, well tolerated and provides a new treatment option for patients with schizophrenia.
Abstract: Paliperidone extended-release tablet (paliperidone ER; INVEGA()) is an oral antipsychotic for the treatment of schizophrenia. The recommended dose range is 3-12 mg per day. Paliperidone ER utilizes the OROS((R)) delivery system, which allows for once-daily dosing. Its pharmacokinetic profile results in a more stable serum concentration. Paliperidone is 9-hydroxyrisperidone, the chief active metabolite of risperidone. It undergoes limited hepatic metabolism, thereby minimizing the risks of hepatic drug-drug and drug-disease interactions. Three 6-week trials in patients with acute schizophrenia reported that paliperidone ER was effective, well tolerated, and produced clinically meaningful improvements in personal and social functioning compared with placebo. Post-hoc analysis of these trials in various populations, including recently diagnosed, elderly and more severely ill patients, those with sleep disturbances and those with predominant negative symptoms demonstrated improvement as well. Paliperidone ER was also significantly better than placebo in the prevention of symptom recurrence in a 6-month maintenance study. The most common clinically relevant adverse events associated with paliperidone ER were extrapyramidal symptoms, tachycardia and somnolence. The incidence of Parkinsonism, akathisia and use of anticholinergic medications increased in a dose-related manner. Further, modest QTc interval prolongation was observed but did not produce clinical symptoms. Similar to risperidone, paliperidone ER is associated with increases in serum prolactin levels. Overall, paliperidone ER was effective, well tolerated and provides a new treatment option for patients with schizophrenia.

50 citations