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Tablets of paliperidone using compression-coated technology for controlled ascending release

Asian Journal of Pharmaceutical Sciences 2018年第2期13卷 143-154页

作者： Yingying Tang Huan Teng Yanan Shi Haibing He Yu Zhang Tian Yin Cuifang Cai Xing Tang School of Pharmacy Shenyang Pharmaceutical University

The aim of this work was to prepare ascending release compression-coated(CC) tablets with paliperidone(PAL) using a simple manufacturing technique and short manufacturing process.The release behavior and mechanisms in vitro of the final tablets was investigated and evaluated. The PAL CC tablets were comprised of a core layer of high viscosity hydroxypropyl cellulose(HPC-H) and a coating layer of high viscosity hydroxypropyl methylcellulose(HPMCK100 M). Several factors such as materials and core tablet compositions were studied for their influence in the formulation procedure. The drug release mechanism was studied using gravimetric analysis. The data could be fitted to the Peppas model. The ascending drug release results were expressed in terms of the slope of the release curve at different time points.Results showed that the formulation could achieve a good ascending drug release when the weight ratio of PAL was 5:1(core:layer). The fraction of HPC and HPMC was 33 %, and the combination of Eudragit RL-PO was 10%. The ascending release mechanism was due to solvent penetration into the PAL CC tablets, and subsequent drug dissolution from the gelatinous HPC and HPMC matrix erosion. The release mechanism was therefore a combination of diffusion and erosion. This work demonstrated that the compression-coated tablets could achieve controlled ascending release over 24 h for the oral administration systems.

关键词： paliperidone Compression-coated tablet Ascending release Controlled release

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Can semipermeable membranes coating materials influence in vivo performance for paliperidone tri-layer ascending release osmotic pump tablet:In vitro evaluation and in vivo pharmacokinetics study

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Asian Journal of Pharmaceutical Sciences 2015年第2期10卷 128-137页

作者： Guangjing Li Yongjun Wang Hongming Chen Donglei Leng Panqin Ma Yanjie Dong Lifang Gao Zhonggui He School of Pharmacy Shenyang Pharmaceutical UniversityNo.103Wenhua RoadShenyang 110016China Kangya of Ningxia Pharmaceuticals Co.Ltd China

One purpose of this study was to develop a paliperidone(PAL)tri-layer ascending release pushepull osmotic pump(TA-PPOP)tablet which could meet the needs of clinical applications.And another purpose was to investigate whether different coating materials influenced in vivo performance of TA-PPOP.The ascending release mechanism of this trilayer delivery system on theory was elaborated.TA-PPOP was prepared by means of coating with cellulose acetate(CA)or ethyl cellulose(EC).Several 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 behaviors of PAL.In vitro dissolution studies indicated that both the two formulations of different coating materials were able to deliver PAL at an ascending release rate during the whole 24 h test.The in vivo pharmacokinetics study showed that both self-made PPOP tablets with different coating had a good in vitro-in vivo correlation(IVIVC)and were bioequivalent with the brand product,which demonstrated no significant influence of the coating materials on the in vivo release acceleration of TA-PPOP.

关键词： Ascending release Tri-layer osmotic pump paliperidone Cellulose acetate Pharmacokinetics In vitroein vivo correlation

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Development and validation of a rapid and sensitive UHPLCeMS/MS method for the determination of paliperidone in beagle dog plasma

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Asian Journal of Pharmaceutical Sciences 2014年第5期9卷 286-292页

作者： Hongming Chen Longshan Zhao Guangjing Li Donglei Leng Panqin Ma Lijin Tong Tianhong Zhang Shenyang Pharmaceutical University No.103Wenhua RoadShenyang 110016China Kangya of Ningxia Pharmaceutical Co. Ltd.No.6High and New Technology Industrial Development ZoneYinchuan 750002China

In order to evaluate the pharmacokinetic profile of paliperidone extended-release tablets in vivo,a simple and rapid ultra-high performance liquid chromatographyetandem mass spectrometry(UHPLCeMS/MS)method was developed and validated for the determination of paliperidone in beagle dog plasma.paliperidone and diazepam(internal standard)were extracted from plasma samples with diethyl ether,and then separated on a C_(18) column(2.1×50 mm,2.6 mm)under gradient elution with methanol-0.1%formic acid at a flow rate of 0.3 ml/min.The compounds were detected using a triple-quadrupole mass spectrometer equipped with an electrospray ionization(ESI)source.The validated method was linear over the concentration range of 1.00-1000.00 ng/ml and the lower limit of quantitation was 1.00 ng/ml.The intra-day and inter-day precision values were not more than 15%(relative standard deviationpaliperidone extended-release tablets in a beagle dog.

关键词： paliperidone Dog plasma UHPLC-MS/MS Pharmacokinetics

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A randomized,6-week,fixed-dose trial for comparison between citalopram and citalopram-paliperidone combination in the treatment of patients with somatoform disorder

A randomized,6-week,fixed-dose trial for comparison between ...

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2011年浙江省医学会精神病学分会学术年会暨浙江省医师...

作者： Manli Huang Jianbo Hu Ning Wei Lin Chen Shanshan Wang Weihua Zhou Shaohua Hu Yi Xu Benyan Luo Department of Psychiatry First Affiliated HospitalCollege of MedicineZhejiang University Department of Neurology First Affiliated HospitalCollege of MedicineZhejiang University

Objectives To evaluate the effectiveness and tolerability of citalopram versus citalopram-paliperidone combination therapy in patients with somatoform disorders(SD).Methods In this 6-week, randomized,fixed-dose study,60 patients with SD(ICD-10 F45.0),undifferentiated SD(F45.1),and somatoform autonomic dysfunction(F45.3),received citalopram 20 mg/day with or without paliperidone 3mg/day.Four scales were used to evaluate efficacy at the end of 2nd,4th,6th week after treatment:Somatoform Disorders Screening Instrument-7(SOMS-7),subscore of Hamilton Anxiety Scale(HAMA-SOM),17-item Hamilton Depression Scale(HAMD17),and Treatment Emergent Symptom Scale(TESS).Results 1)In the intention to treat population(N=51),the overall response ratio(50%reduction in SMOS-7 scores) was significantly higher in the citalopram-paliperidone group compared to the citalopram group after 6-week treatment(71.4%vs 38.10%,χ2=4.71,P=0.03);2)The SOMS-7 and HAMA-SOM total score of citalopram-paliperidone group decreased more significantly than that of citalopram group,and a significant difference could be observed at the end of 4 weeks of the treatment;3)There was no significant difference between the two groups in adverse effects,and no serious adverse event was reported in both groups.Conclusions Our findings indicate that the combination of paliperidone with citalopram exhibits synergic effects for patients with SD.

关键词： somatoform disorders somatoform disorders screening instrument-7,hamilton anxiety scale citalopram paliperidone

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帕利哌酮缓释片与利培酮治疗精神分裂症的对照研究

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疾病监测与控制 2012年第8期6卷 497-498页

作者：敖登格日勒内蒙古精神卫生中心内蒙古呼和浩特010010

目的为了比较帕利哌酮缓释片与利培酮治疗精神分裂症患者的疗效及安全性的差异。方法选取某精神病院60例精神分裂症患者,随机分成帕利哌酮组和利培酮组各30例,分别采用帕利哌酮缓释片和利培酮进行治疗,观察8周。以阳性及阴性症状量表(PA... 详细信息

目的为了比较帕利哌酮缓释片与利培酮治疗精神分裂症患者的疗效及安全性的差异。方法选取某精神病院60例精神分裂症患者,随机分成帕利哌酮组和利培酮组各30例,分别采用帕利哌酮缓释片和利培酮进行治疗,观察8周。以阳性及阴性症状量表(PANSS)减分率评定疗效,用治疗中出现的症状量表(TESS)评定不良反应,以个人和社会功能量表(PSP)评定社会功能。结果帕利哌酮组与利培酮组的总显效率(痊愈+显效)和总有效率(痊愈+显效+有效)的差异不显著(P>0.05)。患者治疗后,两组的PANSS总分及各因子分明显降低(P<0.05)。与利培酮组比较,帕利哌酮组的不良反应出现频率低、程度轻微,个人和社会功能恢复快。结论帕利哌酮缓释片是一种安全有效的新型抗精神病药,可以明显改善精神分裂症和分裂样精神病患者的精神病性症状及社会功能。

关键词：精神分裂症帕利哌酮缓释片 Schizophrenia paliperidone extended-release tablet

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