The observational, cross-sectional study of drug utilization 90% and use of dipeptidyl peptidase-4 inhibitor in the patients with type 2 diabetes mellitus

Background: Diabetes is a chronic metabolic disease which affects the quality of life. It leads to multiple complications due to metabolic involvement. Out of multiple drugs used to treat diabetes, dipeptidyl peptidase 4 (DPP-4) inhibitors are comparatively new drugs used for type-2-diabetes mellitus (DM) treatment. This study aimed to find out the drug utilization (DU) 90% and use of DPP-4 inhibitors in patients with type-2-DM.Methods: A prospective, cross-sectional, observational study was conducted at a private healthcare clinic of an endocrinologist in Nashik. Type-2-DM patients of both sexes were selected and a total of 199 patients were enrolled in the study. The consented patients were interviewed and prescription copies were collected. After studying them; statistical analysis was done and results and conclusions were drawn.Results: Out of total prescribed drugs, 58.77% of drugs were anti-diabetics. It was observed that the biguanides were most frequently (25.32%) prescribed while the least prescribed drugs were meglitinide analogues (0.08%). Most commonly utilized anti-diabetic found to be metformin. Vildagliptin 50 mg is the most commonly prescribed drug from DPP-4 inhibitors. Most of the drugs from the DPP-4 inhibitor group came under DU90%.Conclusions:DPP-4 inhibitors are showing wide acceptability by endocrinologists for type-2-DM management, according to this study. Performing repetitive drug utilization pattern study and circulation of standard treatment guidelines to practising physicians can be required. To emphasize the point on generic prescription, more awareness should be created. So that these can responses to further cost-effective and rational prescribing practices.

Assessment of Different Advanced Technologies for Pharma Wastewater Treatment: A Review

Water is a limited resource that is essential for long-term development. In recent years, industrialization has exponentially increased; the pharmaceutical industry has highly profitable growth while also contributing to environmental damage. Many Pharmaceutical industry discharges wastewater into the surrounding containing complex persistent organic compounds which are highly harmful to aquatic life and people’s health. Ultrasonic Cavitation is one of the methods that are used to treat wastewater and reduce the number of harmful substances that are released into the water bodies. In order to attain maximum Chemical Oxygen Demand reduction, present review demonstrates a combination of ultrasonic cavitation method using different oxidizing agents is a practical choice to decrease the hazards from wastewater discharged through pharmaceutical companies

Effect of Formulation Variables on the Stability of a Live, Rotavirus (RV3-BB) Vaccine Candidate using in vitro Gastric Digestion Models to Mimic Oral Delivery

In this work, two different in vitro gastric digestion models were used to evaluate the stability of a live attenuated rotavirus vaccine candidate (RV3-BB) under conditions designed to mimic oral delivery in infants. First, a forced-degradation model was established at low pH to assess the buffering capacity of formulation excipients and to screen for RV3-BB stabilizers. Second, a sequential-addition model was implemented to examine RV3-BB stability under conditions more representative of oral administration to infants. RV3-BB rapidly inactivated at < pH 5.0 (37 °C, 1 h) as measured by an infectivity RT-qPCR assay. Pre-neutralization with varying volumes of infant formula (Enfamil®) or antacid (Mylanta®) conferred partial to full protection of RV3-BB. Excipients with sufficient buffering capacity to minimize acidic pH inactivation of RV3-BB were identified (e.g., succinate, acetate, adipate), however, they concomitantly destabilized RV3-BB in accelerated storage stability studies. Both effects were concentration dependent, thus excipient optimization was required to design candidate RV3-BB formulations which minimize acid-induced viral inactivation during oral delivery while not destabilizing the vaccine during long-term 2–8 °C storage. Finally, a statistical Design -of-Experiments (DOE) study examining RV3-BB stability in the in vitro sequential-addition model identified key formulation parameters likely affecting RV3-BB stability during in vivo oral delivery

Formulation development of a live attenuated human rotavirus (RV3-BB) vaccine candidate for use in low- and middle-income countries

Formulation development was performed with the live, attenuated, human neonatal rotavirus vaccine candidate (RV3-BB) with three main objectives to facilitate use in low- and middle- income countries including (1) a liquid, 2–8°C stable vaccine, (2) no necessity for pre-neutralization of gastric acid prior to oral administration of a small-volume dose, and (3) a low-cost vaccine dosage form. Implementation of a high-throughput RT-qPCR viral infectivity assay for RV3-BB, which correlated well with traditional FFA assays in terms of monitoring RV3-BB stability profiles, enabled more rapid and comprehensive formulation development studies. A wide variety of different classes and types of pharmaceutical excipients were screened for their ability to stabilize RV3-BB during exposure to elevated temperatures, freeze-thaw and agitation stresses. Sucrose (50–60% w/v), PEG-3350, and a solution pH of 7.8 were selected as promising stabilizers. Using a combination of an in vitro gastric digestion model (to mimic oral delivery conditions) and accelerated storage stability studies, several buffering agents (e.g., succinate, adipate and acetate at ~200 to 400 mM) were shown to protect RV3-BB under acidic conditions, and at the same time, minimize virus destabilization during storage. Several optimized RV3-BB candidate formulations were identified based on negligible viral infectivity losses during storage at 2–8°C and −20°C for up to 12 months, as well as by relative stability comparisons at 15°C and 25°C (up to 12 and 3 months, respectively). These RV3-BB stability results are discussed in the context of stability profiles of other rotavirus serotypes as well as future RV3-BB formulation development activities

Developing a manufacturing process to deliver a cost effective and stable liquid human rotavirus vaccine

Despite solid evidence of the success of rotavirus vaccines in saving children from fatal gastroenteritis, more than 82 million infants worldwide still lack access to a rotavirus vaccine. The main barriers to global rotavirus vaccine coverage include cost, manufacturing capacity and suboptimal efficacy in low- and lower-middle income countries. One vaccine candidate with the potential to address the latter is based on the novel, naturally attenuated RV3 strain of rotavirus, RV3-BB vaccine administered in a birth dose strategy had a vaccine efficacy against severe rotavirus gastroenteritis of 94% at 12 months of age in infants in Indonesia. To further develop this vaccine candidate, a well-documented and low-cost manufacturing process is required. A target fully loaded cost of goods (COGs) of ≤$3.50 per course of three doses was set based on predicted market requirements. COGs modelling was leveraged to develop a process using Vero cells in cell factories reaching high titers, reducing or replacing expensive reagents and shortening process time to maximise output. Stable candidate liquid formulations were developed allowing two-year storage at 2–8 °C. In addition, the formulation potentially renders needless the pretreatment of vaccinees with antacid to ensure adequate gastric acid neutralization for routine oral vaccination. As a result, the formulation allows small volume dosing and reduction of supply chain costs. A dose ranging study is currently underway in Malawi that will inform the final clinical dose required. At a clinical dose of ≤6.3 log10 FFU, the COGs target of ≤$3.50 per three dose course was met. At a clinical dose of 6.5 log10 FFU, the final manufacturing process resulted in a COGs that is substantially lower than the current average market price, 2.44 USD per dose. The manufacturing and formulation processes were transferred to BioFarma in Indonesia to enable future RV3-BB vaccine production

The Effect of Rural-to-Urban Migration on Obesity and Diabetes in India: A Cross-Sectional Study

Shah Ebrahim and colleagues examine the distribution of obesity, diabetes, and other cardiovascular risk factors among urban migrant factory workers in India, together with their rural siblings. The investigators identify patterns of change of cardiovascular risk factors associated with urban migration