In the present study a new co-crystal of Ticagrelor with L-Tartaric acid has been prepared with improved solubility. Ticagrelor is a class VI drug with poor solubility and permeability; hence an attempt has been made to improve its solubility by co-crystallization technology.A co-crystal is a structurally homogeneous crystalline material containing an API and the co-former in definite stoichiometric amounts. In this study the conformer selected was L-Tartaric acid based on ease of hydrogen bond formation. The co-crystal of Ticagrelor with L-Tartaric acid was prepared in different ratios (1:1, 2:1, 1:2). Ticagrelor formed stable co-crystals in the ratios 1:1and2:1. The formation of co-crystal was confirmed by FTIR, DSC and PXRD. The dynamic solubility of co-crystals in the ratios 1:1 and 2:1 was increased by approximately 2.7 and 2.6 fold respectively as compared to pure drug. The in-vitrodissolution study demonstrated a 1.5 fold increase in the solubility for selected TIC:L-TAR (1:1) as compared to its TIC active pharmaceutical ingredient and TIC physical mixture.
Co-crystal synthesis has become a field of high interest in the last decade. This category of solid forms has a variety of applications in industries such as textile, paper and electronics. For many purposes co-crystals will have superior properties in comparison to traditional salt crystals. This review article will focus on the application of co-crystals in pharmaceutical drugs. Co-crystals have opened doors to reintroduce previously poor performing bioactive ingredients in new and improved solid structures. They have also allowed for the introduction of a new range of compounds for pharmaceutical therapy. Most importantly, co-crystals can create new medicines with increased solubility and hence improve the efficiency and safety of the treatment.
Objectives: This current research work aimed for improvement of the solubility and permeability of poorly permeable Doxorubicin HCl through generating co-crystals. The main goal for the preparation of oral drugs is to decrease the overall cost of healthcare and route of administration is made easy. Methodology: In this study co-crystals of Doxorubicin HCl with Quercetin hydrate and Naringin has been prepared based on ease of hydrogen bond formation. The co-crystal batches of Doxorubicin HCl-Quercetin hydrate in ratio 1:1, 1:2, 2:1 and Doxorubicin HCl-Naringin in ratio 1:1 are prepared by slow solvent evaporation technique. Results and Discussion: The formation of co-crystal was confirmed by PXRD, DSC and FTIR. Doxorubicin HCl with Naringen crystal batch show improved solubility. The dynamic solubility of Doxorubicin HCl-Naringin co-crystal in the ratios 1:1 increased by approximately 9.2-fold as compared to pure drug and Doxorubicin HCl-Quercetin hydrate cocrystal batches.
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In this present study a new co-crystals of zoledronic acid with DL-tartaric acid and nicotinamide has been developed with improved solubility. Zoledronic acid is a class III drug with poor oral bioavailability due to its poor permeability and low aqueous solubility; hence an attempt has been made to improve its solubility by co-crystallization technology. Pharmaceutical cocrystals are multi-component crystals with a stoichiometric ratio of active pharmaceutical ingredients (APIs) and cocrystal coformers (CCFs) that are assembled by noncovalent interactions such as hydrogen bonds, π-π packing, and Vander Waals forces. In this study the coformers selected were DL-tartaric acid and nicotinamide based on ease of hydrogen bond formation. The co-crystal of zoledronic acid with DL-tartaric acid were prepared in three ratios (1 : 1, 1 : 2 and 2 : 1) by slow solvent evaporation method and with nicotinamide in 1 : 1 ratio by dry grinding method. The formation of co-crystal was confirmed by powder X-ray diffractometry (PXRD), differential scanning calorimetry (DSC) and Fourier transform (FT)IR. The dynamic solubility of co-crystals with DL-tartaric acid in the ratios 1 : 1, 1 : 2 and 2 : 1 increased by fold as compared to pure drug.
Purpose: Pharmaceutical industry ensures that data entered for various steps of drug development is accurate, which gives us confidence that the drugs produced by the industry are within specified parameters. Data integrity indicates sustaining and assuring the accuracy and reliability of data throughout the life cycle of the product. Over the years, numerous leading regulatory authorities have communicated their expectations in the form of regulations and guidance documents from the US FDA, MHRA, EMA, PIC/S and WHO, which address data management and data integrity issues. However, with an increase in digitalisation and the role of global markets, data integrity failures have increased. This results in recalls of products, warning letters, seizures, legal action and ultimately the potential for patient harm. Materials and Methods: Over the last few years, several regulatory agencies have acted against data integrity deficiencies in the pharmaceutical industry. In 2016, more than 50% of MHRA warning letters involved data integrity lapses for computerized systems were observed compared to year 2015. Broadly, the U.S. approximately has received 15 percent of the warning letters, European countries have received approximately 8 percent and the rest of the world claims approximately 15 percent from FDA in the years 2008-2018. MHRA published a guidance document on data integrity in the March 2015 and its revised draft copy was published in March 2018 which applies to GxP systems. Results: From a quality standpoint, data integrity plays a pivotal role in a company's quality system. Data management and data governance should be efficiently integrated into the quality management system. Conclusion: This article represents the evaluation of warning letters from the last ten years regarding data integrity deficiencies.
Any medicinal product introduced in the market ought to have the highest safety, quality, purity and efficacy as it is received by an ailing patient. Parenteral products are sterile pharmaceutical preparations that are injected, infused or implanted in the body. These products must maintain their quality and sterility as they are introduced directly into the bloodstream. Negligence associated with parenteral preparations can lead to severe or fatal adverse events. Although each country has its own regulatory body to keep a check on medication errors, defects keep occurring in pharmaceutical products. It should be the top priority of pharmaceutical companies to avoid these defects and related issues. This study focuses on three such real life defective parenteral products obtained from the hospital pharmacy. The probable root cause, remediation and clinical significance of the noted defect is also mentioned. These case studies can help pharmaceutical manufacturers minimize defects, quality issues to avoid product recalls and to achieve better therapeutic compliance.
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