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.

Etravirine is a drug used alongside other medication in the treatment of HIV and is a non-nucleoside reverse transcriptase inhibitor. It is a BCS class IV drug, having low solubility and high permeability (Drugbank, https://www.drugbank.ca/drugs/DB06414) [1]. As a result, large doses of the drug are required for treatment. Two pills have to be taken twice a day, making it a “pill burden” (Intelence, http://www.intelence.com/hcp/dosing/administration-options) [2]. Therefore, attempts of co-crystallizing Etravirine are attractive as the solubility of the drug tends to increase in this solid form (Schultheiss and Newman, 2009) [3].In this study Etravirine co-crystals were synthesized in the molar ratios 1:1, 1:2 and 2:1 with L-tartaric acid as the co-former. Both slow evaporation and physical mixture was performed to mix the components. DSC values of final products are presented as well as FTIR spectra to observe the altered intermolecular interactions. A chemical stability test was performed after seven days using area under curve data from an HPLC instrument.

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.