Jiangsu Aosaikang Pharmaceutical Co.

Nanjing, China

Jiangsu Aosaikang Pharmaceutical Co.

Nanjing, China
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Chen H.-Y.,Jiangsu Aosaikang Pharmaceutical Co. | Feng J.-J.,Jiangsu Aosaikang Pharmaceutical Co. | Song T.-T.,Jiangsu Aosaikang Pharmaceutical Co.
Chinese Journal of New Drugs | Year: 2017

Irritable bowel syndrome(IBS) is the most common functional gastrointestinal disorder, in which patients with diarrhea-predominant IBS (IBS-D) comprise a substantial proportion of the overall IBS population. However, many patients have persistent symptoms without effective therapies at present, so the unmet need for special treatment still exists. Eluxadoline is the first and only approved mu-opioid receptor agonist/delta opioid receptor antagonist/kappa-receptor agonist for IBS-D. It has properties of anti diarrheal and abdominal pain-relieving without constipation, which may be explained by its mechanism. Eluxadoline is approved by FDA in May 27th 2015. In this paper, we briefly reviewed the pharmacology, pharmacokinetics, clinical studies and adverse events of eluxadoline. © 2017, Chinese Journal of New Drugs Co. Ltd. All right reserved.

Kan S.,China Pharmaceutical University | Kan S.,Jiangsu Aosaikang Pharmaceutical Co. | Lu J.,China Pharmaceutical University | Liu J.,China Pharmaceutical University | And 2 more authors.
Asian Journal of Pharmaceutical Sciences | Year: 2014

The study aims to prepare naproxen enteric-coated pellets (NAP-ECPs) by fluid-bed coating using QbD principle. Risk assessment was firstly performed by using failure mode and effect analysis (FMEA) methodology. A Plackett-Burman design was then used for assessment of the most important variables affecting enteric-coated pellets characteristics. A Box-Behnken design was subsequently used for investigating the main, interactive, and quadratic effects of these variables on the response. By FMEA we discovered that eight factors should be considered to be high/important risk variables as compared with others. The responses of acid resistance and cumulative drug release were taken as critical quality attributes (CQAs). Pareto ranking analyses indicated that the coating weight gain (X7), triethyl citrate percentage (X1) and glycerol monostearate percentage (X2) were the most significant factors affecting the selected responses out of the eight high-risk variables. Optimization with response surface method (RSM) further fully clarified the relationship between X7, X1, X2 and CQAs, and design space was established based on the constraints set on the responses. Due to the extreme coincidence of the predicted value generated by model with the observed value, the accuracy and robustness of the model were confirmed. It could be concluded that a promising NAP-ECPs was successfully designed using QbD approach in a laboratory scale. © 2014 Shenyang Pharmaceutical University.

He W.,China Pharmaceutical University | Yang K.,China Pharmaceutical University | Fan L.,China Pharmaceutical University | Fan L.,Jiangsu Aosaikang Pharmaceutical Co. | And 6 more authors.
International Journal of Pharmaceutics | Year: 2015

Oral drug delivery is the most preferred route for patients; however, the low solubility of drugs and the resultant poor absorption compromise the benefits of oral administration. On the other hand, for years, the overwhelmingly accepted mechanism for enhanced oral absorption using lipid nanocarriers was based on the process of lipid digestion and drug solubilization in the small intestine. Few reports indicated that other bypass pathways are involved in drug absorption in the gastrointestinal tract (GIT) for oral delivery of nanocarriers. Herein, we report a new nanoemulsion system with a denatured globular protein with a diameter of 30 nm, soybean protein isolates (SPI), and bile salt as emulsifiers, aiming to enhance the absorption of insoluble drugs and explore other pathways for absorption. A BCS class II drug, fenofibrate (FB), was used as the model drug. The SPI and bile salt-coated Ns with a diameter of approximately 150 nm were prepared via a high-pressure homogenizing procedure. Interestingly, the present Ns could be converted to solid dosage form using fluid-bed coating technology, maintaining a nanoscale size. Most importantly, in a model of in situ rat intestinal perfusion, Ns could penetrate across the intestinal epithelial barrier into the systemic circulation and then obtain biodistribution into other tissues. In addition, Ns significantly improved FB oral absorption, exhibited as a greater than 2- and 2.5-fold increase in Cmax and AUC0-t, respectively, compared to the suspension formulation. Overall, the present Ns are promising nanocarriers for the oral delivery of insoluble drugs, and the penetration of intact Ns across the GIT barrier into systemic circulation may be a new strategy for improved drug absorption with the use of nanocarriers. © 2015 Elsevier B.V. All rights reserved.

Zhou Q.,Jiangsu Province Hospital of Traditional Chinese Medicine | Liu L.,Jiangsu Aosaikang Pharmaceutical Co. | Zhang D.,Jiangsu Province Hospital of Traditional Chinese Medicine | Fan X.,Jiangsu Aosaikang Pharmaceutical Co.
Journal of Liposome Research | Year: 2012

Gemcitabine liposome injection (i.e., stealth liposomes) has facilitated the targeting of gemcitabine for cancer treatment. We systemically reviewed liposome-based drug-delivery systems, which can improve pharmacokinetics, reduce side effects, and potentially increase tumor uptake, for pancreatic cancer therapy. A novel liposomal formulation, which allows for higher tumor-targeting efficiencies and can be used in current clinical trials to treat this challenging disease, has gained great popularity and attention. In this work, a simple, rapid high-performance liquid chromatography (HPLC) method was developed for the simultaneous determination of N-(carbonyl-methoxypolyethylene glycol 2000)-1, 2-distearoyl-sn-glycero-3-phosphoethanolamine sodium salt and neutral colipids cholesterol and hydrogenated soy phosphatidylcholine or distearoyl phosphatidylcholine. Because of the poor ultraviolet absorbance of the lipids, evaporative light-scattering detection (ELSD) was used to monitor the separation. The separation was carried out on a YMC-Pack column (YMC Co., Ltd., Kyoto, Japan). Lipids were eluted using binary linear gradients starting from a mixture of 80% A and 20% B to 100% B in 10 minutes, followed by a 6-minute plateau at 100% B, where A is chloroform/isopropyl alcohol/diethylamine/ trifluoroacetic acid (TFA) (50:50:0.01:0.0025) and B is chloroform/isopropyl alcohol/H2O/diethylamine/TFA (41:50:9:0.01:0.0025). The mobile phase composition was then changed back to initial solvent mixture in 1 minute, and the column was equilibrated for 13 minutes before every subsequent run. Then, 0.025% (v/v) TFA was added into the mobile phase to enhance the retaining of the stealth lipids. This newly developed method enabled direct analysis of liposomes without solvent lipid extraction and was validated to be linear, precise, accurate, specific, and sensitive. The method has been successfully employed in a wide range of lipid-based formulation screening, process development, and stability testing. Further, we describe the simple, rapid HPLC-ELSD method for the simultaneous determination of all the lipids and active pharmaceutical ingredients in various liposome-based drug formulations. The method can quantitate all the lipids of active targeting liposomes, which bond with folic acid. © 2012 Informa Healthcare USA, Inc.

Song T.-T.,Jiangsu Aosaikang Pharmaceutical Co. | Feng J.-J.,Jiangsu Aosaikang Pharmaceutical Co. | Ma R.,Jiangsu Aosaikang Pharmaceutical Co.
Chinese Journal of New Drugs | Year: 2015

Isavuconazole is a novel broad-spectrum triazoleantifungal agent. It was granted the fast-track status and designated Qualified Infectious Disease Product (QIDP), and an orphan drug for the treatment of invasive aspergillosis and mucormycosis by the U.S. Food and Drug Administration (FDA). Isavuconazole demonstrated in vitro coverage of a broad range of yeasts (such as Candida species) and molds (such as Aspergillus species and Mucor species). Isavuconazole is administered as a water-soluble prodrug. Oral and intravenous formulations are available. Due to its prolonged half-life(iv: t1/2=76~104 h, po: t1/2=56~77 h), an once-a-day regimen is possible. In the phase III invasive aspergillosis study, isavuconazole demonstrated non-inferiority to voriconazole. Isavuconazole treatment-relevant adverse events were statistically fewer than voriconazole in the System Organ Classes of hepatobiliary, skin and eye disorders. Isavuconazole contains two adjacent chiral centers, some patents have reported in synthesis of enantiomerically pure compounds. In this article, in vitro antibacterial activity, pharmacokinetic, clinical study and chemical synthesis of isavuconazole were reviewed. ©, 2015, Chinese Journal of New Drugs Co. Ltd. All right reserved.

Zhao J.,Jiangsu Aosaikang Pharmaceutical Co. | Ma J.-J.,Jiangsu Aosaikang Pharmaceutical Co.
Chinese Journal of New Drugs | Year: 2012

Miriplatin is a third-generation platinum compound developed to treat hepatocellular carcinoma (HCC). It is administered via the hepatic artery using the carrier lipiodol that consists of ethyl esters of iodized poppy seed oil. Miriplatin has a high affinity for lipiodol and it is anticipated to exert antitumor effects with prolonged retention along with local lipiodol at the tumor site. Therefore, it is suggested that the active compound released from miriplatin/lipiodol can bind to DNA and produce a cytotoxic effect. The clinical research shows that miriplatin has beneficial curative effect and safety in the treatment of hepatocellular carcinoma. This article will summarize its pharmacology, pharmacokinetics, clinical research, and safety evaluation.

Chen X.,Jiangsu Aosaikang Pharmaceutical Co. | Du Y.,Jiangsu Aosaikang Pharmaceutical Co. | Sun H.,Jiangsu Aosaikang Pharmaceutical Co. | Wang F.,Jiangsu Aosaikang Pharmaceutical Co. | And 2 more authors.
Bioorganic and Medicinal Chemistry Letters | Year: 2014

Two series of novel tricyclic oxazine and oxazepine fused quinazolines have been designed and synthesized. The in vitro antitumor effect of the title compounds was screened on N87, A431, H1975, BT474 and Calu-3 cell lines. Compared to erlotinib and gefitinib, compounds 1a-1h were found to demonstrate more potent antitumor activities. Several derivatives could counteract EGF-induced phosphorylation of EGFR in cells, and their potency was comparable to the reference compounds. Compounds 1a-1h were chosen for further evaluation of EGFR and HER2 in vitro kinase inhibitory activity. Compounds 1b-1f, 1h effectively inhibited the in vitro kinase activity of EGFR and HER2 with similar efficacy as erlotinib and gefitinib. © 2014 Elsevier Ltd. All rights reserved.

Lu J.,China Pharmaceutical University | Kan S.,Jiangsu Aosaikang Pharmaceutical Co | Zhao Y.,China Pharmaceutical University | Zhang W.,China Pharmaceutical University | Liu J.,China Pharmaceutical University
Drug Development and Industrial Pharmacy | Year: 2016

The purpose of this study was to develop the novel naproxen/esomeprazole magnesium compound pellets (novel-NAP/EMZ) depending on EMZ acid-independent mechanism which has been proved to be predominate in the mechanism of co-therapy with nonsteroidal anti-inflammatory drug. The novel-NAP/EMZ compound pellets, composed of NAP colon-specific pellets (NAP-CSPs) and EMZ modified-release pellets (EMZ-MRPs), were prepared by fluid-bed coating technology with desired in vitro release profiles. The resulting pellets were filled into hard gelatin capsules for in vivo evaluation in rats and compared with the reference compound pellets, consisted of NAP enteric-coated pellets (NAP-ECPs) and EMZ immediate-release pellets (EMZ-IRPs). The reference compound pellets were prepared simulating the drug delivery system of VIMOVO®. In vivo pharmacokinetics, EMZ-MRPs had significantly larger AUC0– t (p < 0.01), 1.67 times more than that of EMZ-IRPs, and prolonged mean residence time (7.55 ± 0.12 h) than that of IRPs (1.46 ± 0.39 h). NAP-CSPs and NAP-ECPs showed similar AUC0– t. Compared to the reference compound pellets, the novel-NAP/EMZ compound pellets did not show distinct differences in histological mucosal morphology. However, biochemical tests exhibited enhanced total antioxidant capacity, increased nitric oxide content and reduced malondialdehyde level for novel-NAP/EMZ compound pellets, indicating that the acid-independent action took effect. The gastric pH values of novel-NAP/EMZ compound pellets were at a low and stable level, which could ensure normal physiological range of human gastric pH. As a result, the novel-NAP/EMZ compound pellets may be a more suitable formulation with potential advantages by improving bioavailability of drug and further reducing undesirable gastrointestinal damages. © 2016 Taylor & Francis

Dong J.,China Pharmaceutical University | Gong Y.,China Pharmaceutical University | Liu J.,China Pharmaceutical University | Chen X.,Jiangsu Aosaikang Pharmaceutical Co. | And 2 more authors.
Bioorganic and Medicinal Chemistry | Year: 2014

All eight stereoisomers of saxagliptin have been synthesized and evaluated for their inhibitory activity against DPP-IV. It was unambiguously confirmed that the configuration of saxagliptin was critical to potent inhibition of DPP-IV. Docking study was performed to elucidate the configuration-activity relationship of saxagliptin stereoisomers. Tyr662 and Tyr470 have been suggested as the key residues of DPP-IV interacting with the inhibitors. This work provides valuable information for further inhibitor design against DPP-IV. © 2014 Elsevier Ltd. All rights reserved.

Jiangsu Aosaikang Pharmaceutical; Co. | Date: 2012-10-24

Medicines for human purposes for the treatment of gastrointestinal diseases; dietetic food preparations, namely, crackers adapted for medical purposes; tonics medicine for human purposes for the treatment of gastrointestinal diseases; milk powder for infants; dental lacquer; disinfecting paper tissue impregnated with disinfecting chemicals or compounds therefor for use on railings, countertops and toilet seats; first aid kits; depuratives for the body; preparations for destroying vermin. Chemical research; cosmetic research; chemical analysis; chemistry services; biological research; bacteriological research; research and development for others; quality checking and testing; industrial design; computer software consultancy. Health care; physical therapy; pharmaceutical advice; services of a psychologist, namely, psychological counseling; guidance on diet nutrition; landscape gardening; animal breeding; pharmacists services to make up prescriptions; health spa services, namely, health spa services for health and wellness of the body and spirit; telemedicine services.

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