scholarly journals Recent Advances in Pharmaceutical Cocrystals: From Bench to Market

2021 ◽  
Vol 12 ◽  
Author(s):  
Ravi Kumar Bandaru ◽  
Smruti Rekha Rout ◽  
Gowtham Kenguva ◽  
Bapi Gorain ◽  
Nabil A. Alhakamy ◽  
...  
Keyword(s):  
Pharmacokinetic Profile ◽  
Pharmaceutical Compounds ◽  
Dosage Forms ◽  
Active Pharmaceutical Ingredients ◽  
Design Development ◽  
Pharmaceutical Dosage Forms ◽  
Pharmaceutical Cocrystals ◽  
Pharmaceutical Ingredients ◽  
Regulatory Guidelines ◽  
Pharmaceutical Industries

The pharmacokinetics profile of active pharmaceutical ingredients (APIs) in the solid pharmaceutical dosage forms is largely dependent on the solid-state characteristics of the chemicals to understand the physicochemical properties by particle size, size distribution, surface area, solubility, stability, porosity, thermal properties, etc. The formation of salts, solvates, and polymorphs are the conventional strategies for altering the solid characteristics of pharmaceutical compounds, but they have their own limitations. Cocrystallization approach was established as an alternative method for tuning the solubility, permeability, and processability of APIs by introducing another compatible molecule/s into the crystal structure without affecting its therapeutic efficacy to successfully develop the formulation with the desired pharmacokinetic profile. In the present review, we have grossly focused on cocrystallization, particularly at different stages of development, from design to production. Furthermore, we have also discussed regulatory guidelines for pharmaceutical industries and challenges associated with the design, development and production of pharmaceutical cocrystals with commercially available cocrystal-based products.

An Overview of Excipients Classification and Their Use in Pharmaceuticals

2020 ◽  
Vol 16 ◽  
Author(s):  
Cansel Kose Ozkan ◽  
Ozgur Esim ◽  
Ayhan Savaser ◽  
Yalcin Ozkan
Keyword(s):  
Drug Delivery ◽  
Drug Delivery Systems ◽  
Dosage Form ◽  
Dosage Forms ◽  
Design Development ◽  
Pharmaceutical Dosage Form ◽  
Pharmaceutical Dosage Forms ◽  
Product Identification ◽  
Direct Administration ◽  
Active Substances

: The content and the application of pharmaceutical dosage forms must meet several basic requirements to ensure and maintain efficiency, safety and quality. A large number of active substances have limited ability to direct administration. Excipients are generally used to overcome the limitation of direct administration of these active substances. However, the function, behavior and composition of the excipients need to be well known in the design, development and production of pharmaceutical dosage forms. In this review, excipients used to assist in any pharmaceutical dosage form production processes of drugs, to preserve, promote or increase stability, bioavailability and patient compliance, to assist in product identification / separation, or to enhance overall safety and effectiveness of the drug delivery system during storage or use are explained. Moreover, the use of these excipients in drug delivery systems are identified. Excipient toxicity, which is an issue discussed in the light of current studies, also discussed in this review.

Recent Advancements in Pharmaceutical Cocrystals, Preparation Methods and Their Applications

2021 ◽  
Vol 27 ◽  
Author(s):  
Deeksha Manchanda ◽  
Arun Kumar ◽  
Arun Nanda
Keyword(s):  
Aqueous Solubility ◽  
Active Pharmaceutical Ingredient ◽  
Preparation Methods ◽  
Pharmaceutical Dosage Forms ◽  
Physiochemical Properties ◽  
Pharmaceutical Cocrystals ◽  
Regulatory Guidelines ◽  
Development Pipeline ◽  
Covalently Linked ◽  
Further Development

The issue of poor aqueous solubility is a major hurdle in pharmaceutical dosage forms design. A large number of active molecules in the research and development pipeline are known to possess poor aqueous solubility and hence are not suitable for further development. Therefore, the pharmaceutical industry is continuously in search of techniques to tackle the issue of poor solubility. Cocrystallization has gained popularity as one such technique for the modulation of physicochemical properties of an active pharmaceutical ingredient (API). Pharmaceutical cocrystals consists of an API non-covalently linked to a crystal former or coformer that plays an important role in the imparting the desired properties to the cocrystal. Cocrystallization of an API with a suitable coformer not only enhances solubility but also helps in tweaking other physiochemical properties such as stability, bioavailability, mechanical properties, etc. without any change in the pharmacological activity of the API. The past decade saw an enormous growth in cocrystal research which paved the way for drug-drug, higher order and nano-sized cocrystals and further exploration of the applications of cocrystals is still going on. Recently FDA and EMA released regulatory guidelines for pharmaceutical cocrystals which grant them a status similar to that of polymorphs and salts which in turn opened a wider prospect for pharmaceutical cocrystals in terms of intellectual property.

Validated UV Spectrophotometric Methods for the Estimation of Letrozole in Solid Dosage Forms

2018 ◽  
Vol 11 (3) ◽  
pp. 4129-4135
Author(s):  
Suryakanta Swain ◽  
Bikash Ranjan Jena ◽  
Manohar Babu Sitty ◽  
Debi Prasad Pradhan
Keyword(s):  
Phosphate Buffer ◽  
Uv Light ◽  
Dosage Forms ◽  
Solid Dosage Forms ◽  
Pharmaceutical Dosage Forms ◽  
Spectrophotometric Methods ◽  
Solid Dosage ◽  
Accuracy And Precision ◽  
Pharmaceutical Industries ◽  
Cost Efficient

The main intent of this research is to develop two new simple, novel, cost efficient and precise UV spectrophotometric methods for estimation of letrozole in pure and pharmaceutical dosage forms. For estimation of letrozole based on the measurement of UV light absorption, the spectras of letrozole were scanned efficiently and it exhibits maximum absorption wavelength (λmax) at 240nm for Method A and 245nm for Method B. The analysis was carried out against phosphate buffer pH 6.8 (Method A) and phosphate buffer pH 3.8 (Method B) respectively.  The drug shows linear response commencing from 0.5-20 µg/mL for both methods A & B. The regression equation was found as Y= 0.099X + 0.079 (Method A) and Y= 0.1359x + 0.0048 (Method B), and correlation coefficient were 0.999 (Method A) and 0.9999 (Method B). The method validation was accomplished as per the regulation of ICH Q2R1 guidelines for linearity, accuracy, and precision studies. These reported methods have good reproducibility with percentage RSD less than one. These methods were extended towards the formulation and there was no interruption from excipients in the formulation. Hence, these proposed methods can be effectively employed for evaluation of letrozole in quality control as well as routine analysis work in pharmaceutical industries.  

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