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Trevor C Chopko, Craig W Lindsley
After identifying the influence of serotonergic receptors in ameliorating the negative symptoms associated with schizophrenia, atypical antipsychotics were developed incorporating dopamine and serotonin antagonism. Risperidone, sold under the trade name Risperdal, was the second atypical antipsychotic developed following clozapine, but quickly became a first-line treatment for acute and chronic schizophrenia due to its preferential side effect profile. Despite initial FDA-approval 25 years ago, risperidone continues to be a fundamental treatment in schizophrenia, bipolar I disorder, and autism-related irritability...
April 25, 2018: ACS Chemical Neuroscience
John W Jackson, Lisa Fulchino, James Rogers, Helen Mogun, Jennifer Polinski, David C Henderson, Sebastian Schneeweiss, Michael A Fischer
OBJECTIVE: To quantify and explain variation in use of long-acting injectable antipsychotics (LAIs) in the United States, and understand the relationship between patient characteristics, drug reimbursement policies, and LAI prescribing after relapse. METHODS: A cohort of recently relapsed patients with schizophrenia ages 18 to 64, were identified immediately after discharge from a related inpatient hospitalization, partial hospitalization, or emergency room visit, drawn from 2004 to 2006 Medicaid claims, and followed for 90 days until LAI initiation...
January 2018: Pharmacoepidemiology and Drug Safety
John Garner, Sarah Skidmore, Haesun Park, Kinam Park, Stephanie Choi, Yan Wang
Drug-loaded polymeric microparticles have been used as long-acting injectable (LAI) depot formulations. To obtain U.S. Food and Drug Administration approval, a generic LAI depot product needs to be qualitatively (Q1) and quantitatively (Q2) the same in terms of inactive ingredients as its reference-listed drug. However, Q1/Q2 sameness as the reference-listed drug does not guarantee the same in vitro drug release profile and in vivo performance, especially when the manufacturing methods are different. There is little consensus on how the in vitro testing needs to be done to examine the release profiles of LAI depot formulations...
January 2018: Journal of Pharmaceutical Sciences
Florent Auger, Françoise Martin, Olivier Pétrault, Jennifer Samaillie, Thierry Hennebelle, Mohamed-Sami Trabelsi, François Bailleul, Bart Staels, Régis Bordet, Patrick Duriez
Antipsychotics, such as risperidone, increase food intake and induce alteration in glucose and lipid metabolism concomitantly with overweight and body fat increase, these biological abnormalities belong to the metabolic syndrome definition (high visceral adiposity, hypertriglyceridemia, hyperglycemia, low HDL-cholesterol and high blood pressure). Curcumin is a major component of traditional turmeric (Curcuma longa) which has been reported to improve lipid and glucose metabolism and to decrease weight in obese mice...
February 2018: Metabolic Brain Disease
Miranda M C van Beers, Cees Slooten, Jelte Meulenaar, Ahmad S Sediq, Ruud Verrijk, Wim Jiskoot
The purpose of this study was to explore the potential of flow imaging microscopy to measure particle size and agglomeration of poly(D,L-lactic-co-glycolic acid) (PLGA) microparticles. The particle size distribution of pharmaceutical PLGA microparticle products is routinely determined with laser diffraction. In our study, we performed a unique side-by-side comparison between MFI 5100 (flow imaging microscopy) and Mastersizer 2000 (laser diffraction) for the particle size analysis of two commercial PLGA microparticle products, i...
April 6, 2017: European Journal of Pharmaceutics and Biopharmaceutics
Mohsin Kazi, Hassan Al-Qarni, Fars K Alanazi
Liquid adsorption on solid adsorbent carriers is an emerging technique for oral lipid-based drug delivery systems. The purpose of the current study is to convert liquid into solid self-emulsifying lipid formulations (SELFs) using an inorganic adsorbent Neusilin® grade US2 (NUS2) and investigate in vitro dissolution and digestion performance of the model antipsychotic compound risperidone. METHODS: The liquid SELFs were designed using various oils, nonionic surfactants and converted into solid at various SELF: NUS2 (%m/m) mixing ratios...
May 2017: European Journal of Pharmaceutics and Biopharmaceutics
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
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