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During pharmaceutical or biopharmaceutical drug product development, one of the most important steps to be followed is characterization and reverse engineering of the drug product. Out of so many characterization tools and orthogonal reverse engineering techniques, thermoanalytical methods are the most useful techniques. Different thermoanalytical techniques are used to identify, quantify and understand the interaction between different polymorphic forms of drug substances and excipients. These techniques are also used to monitor the physical form (amorphous or crystalline) of the drug substance in drug product throughout its manufacturing processes and helps in identifying, omitting or modifying the steps or processes responsible for change in physical or polymorphic form of the drug substance in the finished drug product. Thermoanalytical techniques are not only useful for characterization of small molecules but also extensively applied in analysis of biological samples and nano-formulations. In current scenario, pharmaceutical development specifically during generic drug development the most useful step is the 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 limited use of thermoanalytical techniques were unavailability of software or compatible hardware, manual sampling process and a tedious process of manual calculation which consumes lots of time. Now a day, due to advancement of technology, automation, use of robotics, and better understanding, and 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), Thermogravimetric 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.
During pharmaceutical or biopharmaceutical drug product development, one of the most important steps to be followed is characterization and reverse engineering of the drug product. Out of so many characterization tools and orthogonal reverse engineering techniques, thermoanalytical methods are the most useful techniques. Different thermoanalytical techniques are used to identify, quantify and understand the interaction between different polymorphic forms of drug substances and excipients. These techniques are also used to monitor the physical form (amorphous or crystalline) of the drug substance in drug product throughout its manufacturing processes and helps in identifying, omitting or modifying the steps or processes responsible for change in physical or polymorphic form of the drug substance in the finished drug product. Thermoanalytical techniques are not only useful for characterization of small molecules but also extensively applied in analysis of biological samples and nano-formulations. In current scenario, pharmaceutical development specifically during generic drug development the most useful step is the 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 limited use of thermoanalytical techniques were unavailability of software or compatible hardware, manual sampling process and a tedious process of manual calculation which consumes lots of time. Now a day, due to advancement of technology, automation, use of robotics, and better understanding, and 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), Thermogravimetric 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.
A “drug delivery system” should be able to reduce toxicity and improve therapeutic benefits. The present investigation aimed to provide an approach for the solubility and bioavailability enhancement by a novel polymer platform Drug delivery system. Platform technology contains a polymeric system with a release modulator and can accommodate drugs with common physicochemical /therapeutic properties with minimal changes. Pioglitazone, BCS class II drug results in sub-therapeutic plasma drug levels which can cause failure in therapeutic response. When it comes to make PIO dissolved and soluble, microwave assisted ball milling technique was followed. Chitosan and neusiline US2 were used to prepare solid dispersion forming ternary complexation. Optimization of solid dispersion of ternary complexation, a “32 level full factorial design with Design Expert Software version 12” had been used. Pioglitazone–CH-neusiline systems helped in marked development of solubility of initial medicinal water, drug dissolution and drug stability. According to the “FTIR, DSC, and XRPD studies, PIO-CH-NS complexes could be prepared by microwave-assisted milling technology has formed stable crystalline in a ternary complex system. A novel polymer platform technique increases bioavailability, enhancing the therapeutic effect while reducing the toxicity of drug molecules with improving patient compliance.
The structural confirmation of the (E)-1-(4-Chlorophenyl)-3-(4-methylphenyl)prop-2-en-1-one compound is done by experimental techniques. Experimental techniques FTIR, proton NMR, UV-Visible, performed for the compound. The experimentally obtained results are compared with theoretically (density functional theory) obtained results. The decomposition and melting point of the compound is obtained by TGA and DTA. Density functional theory is performed for the (E)-1-(4-Chlorophenyl)-3-(4-methylphenyl)prop-2-en-1-one compound B3LYP/6-311G++(d,p) basis set. Time dependent density functional theory calculated for three different methods B3LYP, Hartree-Fock and CAMB3LYP also employed for the MLCC at 6-311G++(d,p) basis set. The MLCC compound is having the total dipole moment 4.45 D. The static (ω=0.0) mean polarizability 17.40 x10-24 esu, anisotropic polarizability 23.37 x10-24esu, first hyperpolarizability 11.84 x10-30 esu, second hyperpolarizability 11.88x10-36 esu. Dynamic mean polarizability (ω=0.0569, ω= 0.04282) 17.84 x 10-24esu, 17.65x10-24esu. Dynamic anisotropic polarizability (ω=0.0569, ω= 0.04282) 24.26 x 10-24esu, 23.86 x10-24esu. Dynamic first hyperpolarizability (ω=0.0569, ω= 0.04282) 18.60 x 10-30 esu, 15.06 x10-30 esu. Dynamic second hyperpolarizability (ω=0.0569, ω= 0.04282) 35.37x10-36 esu, 20.0x10-36 esu.
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