Derivation and Validation of Risk Prediction Model for 30-Day Readmissions Following Transcatheter Mitral Valve Repair.

Transcatheter mitral valve repair (TMVr) has shown to reduce heart failure (HF) rehospitalization and all cause mortality. However, the 30-day all-cause readmission remains high (∼15%) after TMVr. Therefore, we sought to develop and validate a 30-day readmission risk calculator for TMVr. Nationwide Readmission Database from January 2014 to December 2017 was utilized. A linear calculator was developed to determine the probability for 30-day readmission. Internal calibration with bootstrapped calculations was conducted to assess model accuracy. The root mean square error and mean absolute error were calculated to determine model performance. Of 8339 patients who underwent TMVr, 1246 (14.2%) were readmitted within 30 days. The final 30-day readmission risk prediction tool included the following variables: Heart failure, Atrial Fibrillation, Anemia, length of stay ≥4 days, Acute kidney injury (AKI), and Non-Home discharge, Non-Elective admission and Bleeding/Transfusion. The c-statistic of the prediction model was 0.63. The validation c-statistic for readmission risk tool was 0.628. On internal calibration, our tool was extremely accurate in predicting readmissions up to 20%. A simple and easy to use risk prediction tool identifies TMVr patients at increased risk of 30-day readmissions. The tool can guide in optimal discharge planning and reduce resource utilization.

Regulatory approval process for advanced dressings in India: an overview of rules.

OBJECTIVE: There is a high rate of death due to burns and wound infections in India. Innovators and manufacturers of wound and burn dressings need to keep themselves abreast of the most current rules governing medical devices. The concept of advanced dressings is emerging in India. However, local manufacturing is hindered by an absence of clear regulatory guidelines. The lack of advanced wound and burn dressings on the market critically affects patient survival rates, while imports from other countries make dressings unaffordable and beyond the reach of most patients. This article presents the details of an approval procedure for advanced dressings and provides manufacturers, innovators and investors with a better understanding of the classification rules, import, export and marketing approval processes. We also discus the reasons for high levels of imports and costs, as well as suggestions on how to address this. METHOD: A critical analysis was conducted of 54 research and review articles, including regulatory guidelines to control the marketing of wound and burn care dressings recommended by international regulatory agencies. CONCLUSION: India is highly dependent on imports of advanced dressings. Due to lack of clear, quality regulatory guidelines, innovators and manufacturers are facing issues while showcasing their product in the Indian market. Thus development of clear quality regulatory guidelines is crucial. Therefore, this article may guide and encourage manufacturers to develop advanced dressings in India.

Patents on brain permeable nanoparticles.

The blood-brain barrier (BBB) presents a combination of physical and electrostatic barriers. It is a highly complex structure that tightly regulates the movement of molecules from the blood to brain, protecting it from injuries and diseases. However, the BBB also significantly precludes the delivery of drugs to the brain, thus, preventing the therapy of a number of neurological disorders like brain cancer, epilepsy, Alzheimer's disease, schizophrenia etc. Numerous drug delivery strategies have been developed to circumvent this barrier. Out of those, one popular approach is the use of nanoparticles. Nanoparticles form solid, colloidal drug delivery system that consists of macromolecular materials in which the active principle is dissolved, entrapped or encapsulated or onto which the active principle is adsorbed or attached. Brain targeted polymeric nanoparticles have been found to increase the therapeutic efficacy and reduce the toxicity for a large number of drugs. By coating the nanoparticles with surfactants, higher concentrations of the drugs can be delivered. The article presents various approaches used in design and delivery of nanoparticles to brain. It also reviews various patents that describe the use of nanoparticles to deliver various neurotherapeutics to brain.

Laboratory dialysis--past, present and future.

Laboratory dialysis, one of the most widely used techniques in biological research is truly a ' gateway technology' . The analogy is to that of a ' gate' of a building through which everybody has to pass, even though they may wish to go to different departments. Similarly, researchers may be working in altogether different areas but all may need to use laboratory dialysis at one stage or the other during the course of their research. Biochemists may use it to purify enzymes, an immunologist may use it to purify monoclonal antibodies from culture supernatants, a chemist may use it as a step in the crystallography process or for purification of ionic liquids, a biotechnologist may use it to study the effectiveness of enzyme immobilization and a drug discovery scientist may use it for determining drug-protein interaction. The present article reviews patents in the field of laboratory dialysis from inception till date, focusing on the various developmental and innovation related milestones during evolution of the technique. It captures the full panorama of a very interesting technique which continues to be as relevant today as it was in 1866 when the term ' dialysis' was first coined.

Phloroglucinol compounds of therapeutic interest: global patent and technology status.

BACKGROUND: Phloroglucinol compounds, both synthetic as well as natural, have shown a vast array of biological activities. There are a wide range of applications of phloroglucinol compounds in pharmaceuticals, cosmetics, textiles, paints and dyeing industries. Although many of the phloroglucinols have shown promising results in various biological assays, very few have reached clinics. OBJECTIVE: To compile the patented information on various therapeutically active phloroglucinol molecules, so that technologies used in isolation and activity assessment of these compounds could be unearthed and the compiled information be utilized for further development of these molecules. METHODS: The European Patent Office database (official website: espacenet.com) was searched with a keyword "phloroglucinol". In addition, patents were searched using names of compounds listed in our previous review. CONCLUSIONS: This class holds potential for development of molecules in various therapeutic areas. There exist a number of patents on preparations that have phloroglucinol compounds as active ingredient(s). Many such preparations have been tested in vitro and/or in vivo for their efficacy and proven to be active and non-toxic. Commercialization of existing technology on phloroglucinol molecules can yield fruitful results.

IPR and technological issues regarding a biopharmaceutical formulation hemoglobin.

Hemoglobin, the protein responsible for the red color of blood plays a very important part in 'life'- it transports oxygen, without which humans cannot survive. The idea of using purified Hemoglobin as a possible universal substitute for red blood cells has been around for almost a century. Hemoglobin formulations have important therapeutic applications, especially in case of trauma and war when requirements for blood may be very large. Manufacture of hemoglobin for use as a biopharmaceutical poses practical challenges, owing to dependence on human expired blood and fragility of the protein molecule. Biotechnology can play a critical role in breaking these barriers, by not only ensuring recombinant production of hemoglobin, but also enhancing stability of the molecule. The present article, based on a review of patents and available literature gives an insight into the IPR and technological issues involved in the commercial production of this 'life-saving' protein. There are more than 250 patents worldwide related to hemoglobin formulation, cross-linking and determination.

Brain permeable nanoparticles.

The brain is one of the least accessible organs of the body, thus making the delivery of neurotherapeutics almost a challenge. Despite its relatively high nutrient support and exchange requirements, the uptake of any compound is strictly regulated by the blood brain barrier (BBB). As a consequence, BBB prevents effective treatment of many severe and life threatening diseases like brain cancer, epilepsy, Alzheimer's disease, schizophrenia etc. Numerous drug delivery strategies have been developed to circumvent this barrier. One such approach is the use of nanoparticles. Nanoparticles form solid, colloidal drug delivery system that consists of macromolecular materials in which the active principle is dissolved, entrapped or encapsulated or onto which the active principle is adsorbed or attached. Brain targeted polymeric nanoparticles have been found to increase the therapeutic efficacy and reduce the toxicity for a large number of drugs. By coating the nanoparticles with surfactants, higher concentrations of drugs can be delivered to the brain. The article presents various approaches used in design and delivery of nanoparticles to brain. It also reviews various patents that describe the use of nanoparticles to deliver various neurotherapeutics and neurodiagnostics to brain.