ABSTRACT
The development of printing ink is a challenge for binder jetting 3D printed preparations, which directly determines the quality of the printed product. This study adopted a 23 full-factor Design of Experiment (DoE) with three central points to optimize the printing ink composition of levetiracetam 3D printed dispersible tablet based on the concept of Quality by Design. Firstly, using polyvinyl pyrrolidone K30, glycerin and polysorbate 20 as independent variables based on 40% (v/v) isopropanol aqueous solution, and weight variation, hardness, friability and dispersion uniformity of the printed tablets were used as dependent variables. Then obtained the design space of the printing ink prescription by DoE model analysis, and the response optimizer was used to obtain the optimal printing ink prescription: isopropanol aqueous solution containing 0.1% (w/w) polyvinyl pyrrolidone K30 and 4.0% (w/w) glycerin. The jetting mechanism and wettability of the printing ink were analyzed, and different strengths of personalized 3D printed tablets were prepared and characterized, which verified the rationality of the printing ink formulation. This study provided a reference for the development of printing ink for binder jetting 3D printed preparations.
ABSTRACT
The efficient and safe delivery of drugs to the therapeutic site through the biofilm has traditionally been a difficult and hot topic in the field of drug delivery. In recent years, alkyl polyglycoside (APG) have become ideal penetration enhancers for drug delivery systems because of their high permeability, good safety and biodegradability, which has attracted wide attention of domestic and foreign researchers. In this paper, the physical and chemical properties, characteristics, action mechanism and application of APG in drug delivery system are reviewed, and its application prospect in drug delivery system is prospected.
ABSTRACT
Objective: To establish a method for the determination of related substances in dexmetomidine hy- drochloride gels,and investigate the compatibility of dexmedetomidine hydrochloride and excipients in the dexmetomi- dine hydrochloride gels. Methods: HPLC was performed on an octadecylsilane bonded silica gel column by a gradient elution with acetonitrile/0.008 mol/L NaH2PO4 solution as mobile phase. Flow rate was 1.0 ml/min. Column temperature was 30℃. Injection volume was 50 μl. Detection wavelength was 210 nm. According to the Basic Technical Guidelines for the Research of Chemical Drug Preparations,dexmetomidine hydrochloride was mixed with excipients in a certain propor- tion,and the mixtures were treated as test sample at the conditions of high temperature(60℃)and strong light(4500± 500)Lx irradiation. Sampling was performed on the 0,10th and 30th day of treatment,respectively. The appearance of the test samples was examined,and related substances in the samples were determined by the established HPLC method. Results: The established HPLC method showed a good specificity and durability,which could be used to accurately and effectively determine the changes of related substances. The appearance of the test samples the mixtures of dexmetomi- dine hydrochloride and excipients showed no changes in the full course of treatment at the tested conditions,and the re- lated substances were also not increased under the same conditions. Conclusion: The selected excipients(HPMC,pro- pylene glycol,methylparaben,sodium benzoate,and benzyl alcohol)all showed a good compatibility with dexmetomi- dine hydrochloride,and the tested mixture samples with the excipients and dexmetomidine hydrochloride were stable un- der the conditions of high temperature and strong light irradiation. These excipients could be used for the formulation screening for the dexmedetomidine hydrochloride gel development.
ABSTRACT
BACKGROUND: The purpose of the current study is to analyze the existing data comparing neoadjuvant chemotherapy with primary debulking surgery (PDS) in patients with advanced ovarian carcinoma. METHODS: Patients with stage IIIC and IV ovarian cancer were identified from articles in Medline, PubMed, Cochrane Library, and EMBASE database (1989 to February 2013). Two authors independently extracted the data. To assess the risk of bias of included literatures, Cochrane Collaboration's risk of bias tool was used. Meta-analysis on literatures was conducted by using RevMan 5.2 software. RESULTS: Two high-quality randomized controlled trials (RCTs) met the inclusion criteria. These multicenter trials randomized 1,220 women with stage IIIc/IV ovarian cancer to NACT or PDS followed by chemotherapy. There were no significant differences between the study groups with regard to overall survival (OS) (1,120 women; HR 0.98; 95% CI 0.85 to 1.14) or progression-free survival (PFS) (1,120 women; HR 1.03; 95% CI 0.91 to 1.16). CONCLUSION: There was no statistical difference in median OS and PFS between the two treatment groups. With regard to selecting who will benefit from NACT, treatment should be tailored to the patient and should take into account respectability, age, histology, stage, and performance status.
