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Chris Hollis, Mary Pennant, José Cuenca, Cris Glazebrook, Tim Kendall, Craig Whittington, Sarah Stockton, Linnéa Larsson, Penny Bunton, Suzanne Dobson, Madeleine Groom, Tammy Hedderly, Isobel Heyman, Georgina M Jackson, Stephen Jackson, Tara Murphy, Hugh Rickards, Mary Robertson, Jeremy Stern
BACKGROUND: Tourette syndrome (TS) is a neurodevelopmental condition characterised by chronic motor and vocal tics affecting up to 1% of school-age children and young people and is associated with significant distress and psychosocial impairment. OBJECTIVE: To conduct a systematic review of the benefits and risks of pharmacological, behavioural and physical interventions for tics in children and young people with TS (part 1) and to explore the experience of treatment and services from the perspective of young people with TS and their parents (part 2)...
January 2016: Health Technology Assessment: HTA
Jie Shen, Stephanie Choi, Wen Qu, Yan Wang, Diane J Burgess
The objective of the present study was to determine whether an in vitro-in vivo correlation (IVIVC) can be established for polymeric microspheres that are equivalent in formulation composition but prepared with different manufacturing processes. Risperidone was chosen as a model therapeutic and poly(lactic-co-glycolic acid) (PLGA) with similar molecular weight as that used in the commercial product Risperdal® Consta® was used to prepare risperidone microspheres. Various manufacturing processes were investigated to produce the risperidone microspheres with similar drug loading (approx...
November 28, 2015: Journal of Controlled Release: Official Journal of the Controlled Release Society
John Garner, Sarah Skidmore, Haesun Park, Kinam Park, Stephanie Choi, Yan Wang
Poly(lactide-co-glycolide) (PLGA) is the key component of long acting drug products responsible for providing sustained release in a controlled manner. The objective of the current study was to develop and validate an analytical protocol to determine key properties of PLGA used in commercial long-acting drug products. Procedures to isolate PLGA from commercial products have been established and the key properties of PLGA, such as polymer molecular weight, lactide:glycolide (L:G) ratio, and nature of polymer end-cap, have been determined...
November 10, 2015: International Journal of Pharmaceutics
Bhanusree Yerragunta, Satheesh Jogala, Krishna Mohan Chinnala, Jithan Aukunuru
OBJECTIVE: The purpose of this study was to develop an ideal microsphere formulation of risperidone that would prolong the drug release for 3 months in vivo and avoid the need for co-administration of oral tablets. MATERIALS AND METHODS: Polycaprolactones (PCL) were used as polymers to prepare microspheres. The research included screening and optimizing of suitable commercial polymers of variable molecular weights: PCL-14000, PCL-45000, PCL-80000 or the blends of these polymers to prepare microspheres with zero-order drug-releasing properties without the lag phase...
January 2015: Journal of Pharmacy & Bioallied Sciences
Celine M Laffont, Roberto Gomeni, Bo Zheng, Christian Heidbreder, Paul J Fudala, Azmi F Nasser
RBP-7000 is a long-acting formulation of risperidone designed for once-monthly subcutaneous injection for the treatment of schizophrenia. The objective was to estimate clinically effective doses of RBP-7000 based on model simulations and on the comparison with other long-acting injectable antipsychotics. A population pharmacokinetic model of RBP-7000 was developed in 90 clinically stable schizophrenic patients having received single/repeated doses of 60, 90, or 120 mg. Model simulations were conducted to compare active moiety plasma exposure after repeated RBP-7000 administrations to the published data of long-acting risperidone injection (Risperdal® Consta®) at 25 and 50 mg, and of paliperidone palmitate (Invega® Sustenna®) at 50 and 100 mg equivalent paliperidone...
January 2015: Journal of Clinical Pharmacology
H Y Meltzer, J-P Lindenmayer, J Kwentus, D B Share, R Johnson, K Jayathilake
It has been suggested that atypical antipsychotic drugs (A-APDs) other than clozapine may be effective to improve positive symptoms in some patients with treatment resistant schizophrenia (TRS), if both the dose is higher, and the duration of the trial longer, than those which have been ineffective in non-TRS (NTRS) patients. This hypothesis was tested with long acting injectable risperidone (Risperdal Consta®, RLAI). One hundred sixty TRS patients selected for persistent moderate-severe delusions or hallucinations, or both, were randomized to RLAI, 50 or 100mg biweekly, in a six month, outpatient, double-blind, multicenter trial...
April 2014: Schizophrenia Research
David Hobbs, Jamie Karagianis, Tamas Treuer, Joel Raskin
BACKGROUND: Orodispersible tablets (ODTs) are tablet or wafer forms of medication that disintegrate in the mouth, aided only by saliva. ODTs rely on different fast dissolve/disintegration manufacturing technologies. OBJECTIVES: Disintegration time differences for several olanzapine ODT forms were investigated. Risperdal M-Tab(®) was included as a non-olanzapine ODT comparator. RESEARCH DESIGN AND METHODS: Eleven olanzapine ODT examples and orodispersible risperidone strengths were evaluated in vitro for formulation composition, manufacturing method, disintegration and dissolution characteristics, and formulation differences in comparison with freeze dried Zydis(®) ODT...
December 2013: Drugs in R&D
Susan D'Souza, Jabar Faraj, Patrick DeLuca
The purpose of this study was to develop a parenteral delivery system of Risperidone that would provide initial and extended drug release and thereby avoid the need for co-administration of oral tablets. Key formulation parameters utilized to achieve desired therapeutic levels in vivo were particle size and drug loading. Three poly (D,L-lactide-co-glycolide) (PLGA) microsphere formulations (Formulations A, B, and C) that encapsulated Risperidone were prepared by varying particle size (19-49 μm) and drug loading parameters (31-37%) but with a uniform bulk density (0...
November 2013: European Journal of Pharmaceutics and Biopharmaceutics
Thomas R Einarson, Roman Zilbershtein, Jana Skoupá, Sárka Veselá, Madhur Garg, Michiel E H Hemels
PURPOSE: The Czech Republic is faced with making choices between pharmaceutical products, including depot injectable antipsychotics. A pharmacoeconomic analysis was conducted to determine the cost-effectiveness of atypical depots. METHODS: An existing 1-year decision-analytic framework was adapted to model drug use in this healthcare system. The average direct costs to the General Insurance Company of the Czech Republic of using paliperidone palmitate (Xeplion®), risperidone (Risperdal Consta®), and olanzapine pamoate (Zypadhera®) were determined...
September 2013: Journal of Medical Economics
Katsuya Takeuchi, Katsumi Sanjo, Akio Sakai
Risperidone, a serotonin-dopamine antagonist, is effective in preventing delusions and hallucinations by D2 receptor antagonism and treating negative symptoms by 5-HT2A receptor antagonism. It is less likely to produce extrapyramidal symptoms than conventional antipsychotics, enabling safe drug therapy for schizophrenia. Paliperidone, based on 9OH-risperidone(major metabolite of risperidone), was developed to make the best use of the high therapeutic efficacy of Risperdal and enable continued treatment with lower prevalence of adverse events...
April 2013: Nihon Rinsho. Japanese Journal of Clinical Medicine
Yun Liu, Meng-qi Zhang, Jing-ying Jia, Yan-mei Liu, Gang-yi Liu, Shui-jun Li, Wei Wang, Li-ping Weng, Chen Yu
BACKGROUND: Risperidone is a benzisoxazole derivate and is effective in the treatment of schizophrenia and other psychiatric illnesses in adults and children. Although there are a few reports in the literature regarding the pharmacokinetic characteristics of risperidone, insufficient data on its pharmacokinetic properties in a Chinese population are available. OBJECTIVE: To meet the requirements for marketing a new generic product, this study was designed to compare the pharmacokinetic properties and bioequivalence of two 2 mg tablet formulations of risperidone: a newly developed generic formulation (test) and a branded formulation (reference) in healthy adult male Chinese volunteers...
March 2013: Drugs in R&D
Pierre S Chue, Erin M MacKenzie, James A Chue, Glen B Baker
Paliperidone, or 9-hydroxyrisperidone (Invega(®), Janssen, Antwerp, Belgium) is the major active metabolite of the atypical antipsychotic risperidone (Risperdal(®), Janssen). It possesses a similar, though not identical, receptor pharmacology to the parent molecule. There are additional differences in terms of its predominant renal metabolism, lower protein binding and decreased inhibition of P-glycoprotein leading to decreased potential for drug-drug interactions. Paliperidone is approved as an extended release (ER) tablet based on an osmotic-controlled release oral Push-Pull™ delivery system (Oral Osmotic System, OROS(®), Alza Corporation) for the treatment of schizophrenia...
December 2012: Expert Review of Neurotherapeutics
(no author information available yet)
For over 40 years, antipsychotic drugs have been used as long-term maintenance treatment to control symptoms and reduce relapse rates in patients with schizophrenia. 'First-generation' oral agents such as haloperidol and chlorpromazine are associated with high levels of unwanted neurological effects and poor rates of patient adherence.1,2 Long-acting ('depot') injections of antipsychotics were developed to try to improve adherence. 'Second-generation' antipsychotic agents (also known as atypical antipsychotics) were introduced into clinical practice over 16 years ago...
September 2012: Drug and Therapeutics Bulletin
Akanksha Sharma, Steven R Shaw
INTRODUCTION: Atypical antipsychotic agents are widely used psychopharmacological interventions for autism spectrum disorders (ASDs). Among the atypical antipsychotic agents, risperidone has demonstrated considerable benefits in reducing several behavioral symptoms associated with ASDs. This meta-analysis examined research regarding the effectiveness of risperidone use among children with ASD using articles published since the year 2000. METHODS: The database for the analyses comprised 22 studies including 16 open-label and six placebo-controlled studies...
July 2012: Journal of Pediatric Health Care
Archana Rawat, Upkar Bhardwaj, Diane J Burgess
The objective was to investigate the relationship between in vitro and in vivo release of commercial Risperdal(®) Consta(®) microspheres. A modified USP apparatus 4 method was used for accelerated and real-time in vitro release testing. The in vivo plasma profile (clinical data) reported for the product was deconvoluted for comparison with the in vitro release profiles. The in vivo profile differed from the real-time in vitro profile and was faster initially and then slower after approximately 30 days. This effect is considered to be due to differences in the in vivo conditions such as small interstitial volume, low pH and immune response...
September 15, 2012: International Journal of Pharmaceutics
Eric J de Waal, Wendy Roosen, Petra Vinken, John Vandenberghe, Patrick Sterkens, Lieve Lammens
RISPERDAL(®) CONSTA(®) is a long-acting, intramuscular formulation of risperidone microspheres for the biweekly treatment of schizophrenia and other psychiatric disorders. In a 24-month carcinogenicity study male and female Wistar Hannover rats received RISPERDAL(®) CONSTA(®) by intramuscular injection at dosages of 5 or 40 mg/kg once every 2 weeks. Bone changes described as "osteodystrophy" were observed by routine microscopic examination at 40 mg/kg in the sternum of female rats after 12 months, and in the sternum and stifle joint of both male and female rats after 24 months of treatment, respectively...
September 28, 2012: Toxicology
Michael J Fellner
Two new cases are presented with delusions of parasitosis. Both were women, one middle-aged and one elderly, and exhibited classic symptoms of parasites and "strings" in the skin indicative of Morgellons disease. Each had an additional psychiatric disorder: drug addiction to cocaine and senile dementia. They also illustrate the difficulty encountered by the dermatologist in providing adequate therapy because of resistance to psychiatric referral as well as to standard accepted medication. Newer psychotropics, such as risperdal and lexapro, show promise in helping these patients and add to the therapeutic armamentarium of pimozide...
March 2012: Skinmed
Archana Rawat, Erika Stippler, Vinod P Shah, Diane J Burgess
The current manuscript addresses the need for a validated in vitro release testing method for controlled release parenteral microspheres. A USP apparatus 4 method was validated with the objective of possible compendial adaptation for microsphere in vitro release testing. Commercial microspheres (Risperdal Consta) were used for method validation. Accelerated and real-time release tests were conducted. The accelerated method had significantly reduced test duration and showed a good correlation with the real-time release profile (with limited number of sample analysis)...
November 28, 2011: International Journal of Pharmaceutics
Nirtal Shah, Yuka Nakamura
PURPOSE: The purpose of this case report is to demonstrate the importance of a thorough patient interview. The case involves a man referred for physical therapy for a musculoskeletal dysfunction; during the patient interview, a psychiatric disorder was recognized that was later identified as schizophrenia. A secondary purpose is to educate physical therapists on the recognizable signs and symptoms of schizophrenia.Client description: A 19-year-old male patient with chronic shoulder, elbow, and wrist pain was referred for physical therapy...
2010: Physiotherapy Canada. Physiothérapie Canada
Andrea Alparone
Structures and IR and Raman spectra of Risperidone in its neutral, mono- and di-protonated forms were calculated in gas phase by DFT-B3LYP/6-31G* level. Mono-protonation occurs at the nitrogen atom of the piperidine ring, while nitrogen atom of the pyrimidine ring is the preferred site for the second protonation. The lowest-energy structure of the mono-protonated Risperidone is characterized by formation of a strong seven-membered O(pyrimidine ring)⋯(+)H-N(piperidine ring) intramolecular hydrogen-bonded cycle...
October 15, 2011: Spectrochimica Acta. Part A, Molecular and Biomolecular Spectroscopy
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