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Characterization and Reverse Engineering of Pharmaceuticals: Role of Thermoanalytical Techniques

Bal, Gobardhan (2023) Characterization and Reverse Engineering of Pharmaceuticals: Role of Thermoanalytical Techniques. Research Journal of Pharmacy and Technology, 16 (10). pp. 4973-4980. ISSN 0974-360X,0974-3618


During pharmaceutical and biopharmaceutical drug product development, the most important step is characterization and reverse engineering. Out of so many tools and techniques, thermoanalytical methods are the most useful techniques. Different thermoanalytical techniques are used to identify, quantify and to understand the interaction between different polymorphic forms of drug substances and excipients. These techniques are used to monitor the physical form (amorphous or crystalline) of the API in drug product throughout its manufacturing process and also help in omitting or modifying the step or process responsible for alternation of the polymorphic form. Thermoanalytical techniques are not only useful for characterisation of small molecules bust also extensively applied in analysis of biological samples and Nano-formulations. In current scenario of pharmaceutical development specifically for generic drug development the most useful step is reverse engineering. When reverse engineering of drug product is concerned, thermoanalytical techniques are the best tools to be used to prove the similarity of physico-chemical properties or same state of matter or arrangement of matter between test and reference products. However, in earlier days these techniques were not used as frequently as the other techniques like spectroscopy and chromatography. Various reasons for less use of thermoanalytical techniques were unavailability of software or compatible hardware and sample analysis as well as calculation was complete manual and tedious process which consumes lots of time. Now a day, due to advancement of technology, automation, use of robotics, and better understanding, the thermal analysis not only become a powerful tool but also increase the throughput. The present review focuses on some of the most commonly used Thermoanalytical techniques e.g. Differential Scanning Calorimeter(DSC), Thermogravimatric Analysis(TGA), Solution Calorimeter(SC), Thermo Mechanical Analysis(TMA) and Isothermal Titration Calorimeter (ITC) for characterization and reverse engineering of different dosage forms like solid oral dosage forms, injectable formulation, inhalation formulation, ophthalmic formulation and biosimilar formulation products such as peptides and proteins using specific case studies.

Item Type: Article
Keywords: Reverse-engineering; Characterization; Differential Scanning Calorimeter (DSC); Thermogravimetric Analysis (TGA); Thermoanalytical Techniques; Thermo Mechanical Analysis (TMA); Isothermal Titration Calorimeter (ITC); Solution Calorimeter (SC).
Date Deposited: 17 Nov 2023 00:45
Last Modified: 17 Nov 2023 00:45