Particle Characterization for a Protein Drug Product Stored in Pre-Filled Syringes Using Micro-Flow Imaging,Archimedes, and Quartz Crystal Microbalance with Dissipation

Micro-flow imaging (MFI) has been used for formulation development for analyzing sub-visible particles. Archimedes, a novel technique for analyzing sub-micron particles, has been considered as an orthogonal method to currently existing techniques. This study utilized these two techniques to investigate the effectiveness of polysorbate (PS-80) in mitigating the particle formation of a therapeutic protein formulation stored in silicone oil-coated pre-filled syringes. The results indicated that PS-80 prevented the formation of both protein and silicone oil particles. In the case of protein particles, PS-80 might involve in the interactions with the hydrophobic patches of protein, air bubbles, and the stressed surfaces of silicone oil-coated pre-filled syringes. Such interactions played a role in mitigating the formation of protein particles. Subsequently, quartz crystal microbalance with dissipation (QCM-D) was utilized to characterize the interactions associated with silicone oil, protein, and PS-80 in the solutions. Based on QCM-D results, we proposed that PS-80 likely formed a layer on the interior surfaces of syringes. As a result, the adsorbed PS-80 might block the leakage of silicone oil from the surfaces to solution so that the silicone oil particles were mitigated at the presence of PS-80. Overall, this study demonstrated the necessary of utilizing these three techniques cooperatively in order to better understand the interfacial role of PS-80 in mitigating the formation of protein and silicone oil particles.     

Physicochemical and Antioxidant Assays of Methanol and Hydromethanol Extract of Ariel Parts of Indigofera tinctoria Linn

Free radicals or reactive oxygen indices give rise to oxidative injury, which is a fundamental mechanism underlying a number of disease like diabetes, cancer, neurodegenerative disorders. Deleterious effects of reactive oxygen species can be nullified by using different natural antioxidants derived from plants Indigofera tinctoria is such plant. This study was planned in order to trace and determine the antioxidant capability of Indigofera tinctoria. All the reagents and chemicals used in this study were obtained from reliable firms. The plant extracts were subjected to phytochemical screening, quantitative assays and antioxidant profiling. The results suggested that plant extracts contained all pharmacologically important phytoconstituents in appreciable amounts and having excellent antioxidant capabilities.     

Bilateral retinal detachment in Goldenhar syndrome

The ocular features of Goldenhar syndrome (GS) are typically external, like surface dermoids and lid coloboma. Retinal detachment (RD) is rare and has not been reported in absence of other concomitant predisposing congenital ocular disorders. We present a unique case of bilateral rhegmatogenous retinal detachment (RRD) with GS. To the best of our knowledge, this association of GS with RRD is novel and has not been reported earlier in ophthalmic and systemic literature on RRD.     

Haemopoietic cell composition of human fetal liver, spleen and thymus

The haemopoietic cell composition of fetal liver, spleen and thymus was studied in human aborted fetuses of 12–22 weeks gestation. Erythroid cells were present primarily in liver and to a lesser extent in spleen. Orthochromatic normoblasts were the predominant erythroid component. Lymphoid cells were seen primarily in the thymus and to a lesser extent in the spleen. There were few granulocytic and megakaryocytic cells in all these organs, A few primitive haemopoietic cells (Haemocytoblasts) were identified only in liver. These observations indicate that during mid-fetal life (12–22 weeks) the liver contributes primarily to erythropoiesis, the thymus to lymphopoiesis, the spleen to both, and that there is a lack of granulopoiesis and megakaryopoiesis at these sites.     

Long-term contraception by a single silastic implant-D containing norethindrone acetate in women: a clinical evaluation

876 women were followed over a 3975-woman-month period after implantation of a single silastic capsule containing 40 mg of norethindrone acetate. Data were analyzed by a life-table method with 3 cut-off dates. Net cumulative pregnancy rate until 7 months was 2.3/100, whereas it rose to 3.9/100 after 8 months of implantation. Net cumulative termination rates rose from .7-10.9 at the end of 7 months and reached 13.6 after 8 months. Removal rates for planned pregnancy, personal, and medical reasons after 8 months were .6, 1.2, and 5.7, respectively. 1.4/100 requested implant removals in preparation for sterilization procedures. Expulsion occurred at a rate of .8/100 at the end of 8 months. The continuation rate was 86.4/100 after 8 months. Menstrual pattern abnormalities showed a reduction with time. This implant seems an acceptable long-term contraception alternative.     

Port site metastasis subsequent to laparoscopy for chronic pelvic pain

We present an interesting case of port site metastasis is a menopausal women subsequent to diagnostic laparoscopy undertaken for chronic pelvic pain, which later proved early ovarian malignancy as the source of primary. While cases of port site metastasis have mostly occurred after extensive disease the possbility of such complication should be in mind at laparoscopy of early cancer.