Elizabeth Varmette,Brianne Strony,Daniel Haines et al.
Elizabeth Varmette et al.
Protein adsorption to primary packaging is one of the problems faced by biopharmaceutical drug companies. An assay was developed to quantify loss of proteins to glass vial surfaces. The assay involves the labeling of protein with a fluoresc...
Barry P Fairand,Niki Fidopiastis
Barry P Fairand
This paper discusses an approach for establishing a sterilization dose for an aseptically processed product after the product is in its final packaged state, in other words, terminal sterilization. It applies to aseptic processes where the ...
Impact of Uncontrolled vs Controlled Rate Freeze-Thaw Technologies on Process Performance and Product Quality [0.03%]
不同冻结解冻技术对生产工艺和产品质量的影响
Chakradhar Padala,Feroz Jameel,Nitin Rathore et al.
Chakradhar Padala et al.
Most biomolecules, owing to their marginal stability in liquid state, susceptibility to microbial growth, and tendency to foam upon storage/shipment in the liquid state, often require an alternate method of long-term storage. Cryopreservati...
Biosimilars [0.03%]
生物类似药
Anurag Rathore
Anurag Rathore
Lactose-Conjugated PLGA Nanoparticles for Enhanced Delivery of Rifampicin to the Lung for Effective Treatment of Pulmonary Tuberculosis [0.03%]
用于有效治疗肺结核的增强型肺递送利福平的乳糖连接PLGA纳米颗粒
Sanjay K Jain,Yashwant Gupta,Lathaeswari Ramalingam et al.
Sanjay K Jain et al.
Lactose conjugated poly(lactic co-glycolic acid) nanoparticles (L-PLGA-NPs) were investigated for lung delivery of rifampicin for effective treatment of pulmonary tuberculosis. Lactose-PLGA conjugate was synthesized using lactose and PLGA a...
Review of solubilization techniques for a poorly water-soluble drug: carbamazepine [0.03%]
卡马西平这一难溶性药物增溶技术的研究进展综述
Mittapalli Pavan Kumar,G Y Srawan Kumar,Shashank Apte et al.
Mittapalli Pavan Kumar et al.
Solubility behavior of drugs remains one of the most challenging aspects in formulation development. With the introduction of various solubility improvement techniques it should be possible to overcome solubility-linked issues. Several year...
Growth-promoting Properties of Different Solid Nutrient Media Evaluated with Stressed and Unstressed Micro-organisms: Prestudy for the Validation of a Rapid Sterility Test [0.03%]
不同固体培养基促进生长的特性：快速无菌试验鉴定的预研究工作应力微生物和非应力微生物
Jennifer Claire Gray,Alexandra Staerk,Manfred Berchtold et al.
Jennifer Claire Gray et al.
Currently, sterility testing in the pharmaceutical industry-a mandatory release test for all sterile drug products-takes an incubation time of at least 14 days and is based on liquid media according to the pharmacopoeias. The search is on f...
Identification of an extraneous black particle in a glass syringe: extractables/leachables case study [0.03%]
玻璃注射器中未知黑色粒子的鉴别：_extractables/leachables_案例研究
Yasser Nashed-Samuel,Gianni Torraca,Dengfeng Liu et al.
Yasser Nashed-Samuel et al.
An unexpected, black particle (∼300 microns) was visually observed adhering to the interior shoulder of a prefilled glass syringe containing a biological drug product. The goal of this study was to determine the source, identity, and leach...
Development and in vitro cytotoxic evaluation of parenteral docetaxel lipid nanoemulsions for application in cancer treatment [0.03%]
用于癌症治疗的多西他赛脂质纳米乳注射剂的开发及体外细胞毒性评价
Isnepally Venkateshwarlu,Kandadi Prabhakar,Mubarak Ali et al.
Isnepally Venkateshwarlu et al.
The aim of the present study was to develop stable lipid nanoemulsions (LNEs) for delivery of docetaxel for treatment of cancer. The LNEs of docetaxel were prepared by using olive oil and egg lecithin by hot homogenization followed by ultra...
Formulation and evaluation of liquisolid compacts of diclofenac sodium [0.03%]
(diclofenac钠(liquisolid片剂的制备与评价
Ajit S Kulkarni,Jayashree B Gaja
Ajit S Kulkarni
The technique of liquisolid compacts is a promising method towards enhancing the dissolution of poorly soluble drugs. In the present study, the potential of liquisolid systems to improve the dissolution properties of water-insoluble agents ...