Thermal Analysis Methods in Pharmaceutical Quality Control

F, Monajjemzadeh F Ghaderi

doi:10.4172/2329-9053.1000e121

Cited by 5 publications

(4 citation statements)

References 19 publications

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“…A DSC is a calorimeter that measures the heat flow rate versus the temperature increase. This method is used to observe the thermal characteristics of a solid material in detail, such as the glass transition, water/solvent release from a pseudopolymorphism, fusion/melting point, recrystallization at high temperature, and decomposition, as well as to observe subtle physical changes, such as the glass transition temperature and eutectic point [22,23,63,64]. The DTA measures the temperature difference that occurs during heating and is commonly combined with a TG in one device.…”

Section: Modern Calorimetry: Dsc and Dta/tgmentioning

confidence: 99%

“…DSC and DTA thermograms will show endothermic and exothermic curves, representing the energy change during the phase transformation. For example, the glass transition is demonstrated by an endothermic blunt curve, a broad endothermic peak indicates water or solvent molecules release, the melting point shows a sharp endothermic curve, a sharp exothermic curve indicates recrystallization, and oxidation/degradation is indicated by some irregular curves [20][21][22][23]. Currently, almost all the multi-component development reports show the DSC data, indicating that this method is adequate for identifying a new entity with a specific energy.…”

Section: Modern Calorimetry: Dsc and Dta/tgmentioning

confidence: 99%

“…Those antibiotics are well absorbed and can be administered orally or parenterally [4]. However, this antibiotic group shows more effectiveness orally [23]. Fluoroquinolones act as bactericidal agents against a broad spectrum of bacteria, such as Escherichia, Salmonella, Shigella, Enterobacter, Campylobacter, Neisseria, and Staphylococcus [1].…”

Section: Fluoroquinolones Multi-component Developmentmentioning

confidence: 99%

“…Therefore, a new structure's thermogram has a different pattern from a single component or physical mixture. Thermal analysis has long been used in pharmaceutical research to identify and detect purity based on phase thermodynamic principles [21][22][23].…”

Section: Introductionmentioning

confidence: 99%

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The Benefits and Challenges of Antibiotics–Non-Steroidal Anti-Inflammatory Drugs Non-Covalent Reaction

2023

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Recently, non-covalent reactions have emerged as approaches to improve the physicochemical properties of active pharmaceutical ingredients (API), including antibiotics and non-steroidal anti-inflammatory drugs (NSAIDs). This review aimed to present and discuss the non-covalent reaction products of antibiotics, including salt and neutral multi-component solid forms, by framing their substituents and molar ratios, manufacturing techniques, characterization methods, benefits, potency changes, and toxicity, and is completed with an analysis of the development of computational models used in this field. Based on the data, NSAIDs are the most-developed drugs in multi-component system preparations, followed by antibiotics, i.e., antituberculosis and fluoroquinolones. They have reacted with inorganic elements, excipients, nutraceuticals, natural products, and other drugs. However, in terms of treatments for common infections, fluoroquinolones are more frequently used. Generally, NSAIDs are acquired on an over-the-counter basis, causing inappropriate medication. In addition, the pKa differences between the two groups of medicine offer the potential for them to react non-covalently. Hence, this review highlights fluoroquinolone–NSAID multi-component solid systems, which offer some benefits. These systems can increase patient compliance and promote the appropriate monitoring of drug usage; the dual drug multi-component solids have been proven to improve the physicochemical properties of one or both components, especially in terms of solubility and stability. In addition, some reports show an enhancement of the antibiotic activity of the products. However, it is important to consider the possibility of activity changes, interaction, and toxicity when using drug combinations. Hence, these aspects also are discussed in this review. Finally, we present computational modeling, which has been utilized broadly to support multi-component system designs, including coformer screening, preparation methods, and structural modeling, as well as to predict physicochemical properties, potency, and toxicity. This integrated review is expected to be useful for further antibiotic–NSAID multi-component system development.

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Section: Modern Calorimetry: Dsc and Dta/tgmentioning

confidence: 99%

Section: Modern Calorimetry: Dsc and Dta/tgmentioning

confidence: 99%

Section: Fluoroquinolones Multi-component Developmentmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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The Benefits and Challenges of Antibiotics–Non-Steroidal Anti-Inflammatory Drugs Non-Covalent Reaction

2023

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Analytical Investigation of the Possible Chemical Interaction of Methyldopa with Some Reducing Carbohydrates Used as Pharmaceutical Excipients

2018

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Purpose: Assessment of drug substance and excipients compatibility is an important issue during pre-formulation studies as well as the quality control of pharmaceutical dosage forms. In this study, potential incompatibility between methyldopa and reducing excipients was evaluated using physicochemical methods.Methods: Dextrose and lactose (anhydrous & monohydrate) were selected as reducing carbohydrates. The initial incompatibility was studied with DSC and FTIR on binary mixtures with 1:1 mass ratio. Results were confirmed using HPLC studies coupled with mass spectrometry.Results: The DSC curves indicated the elimination of the melting endotherm of methyldopa in the binary mixtures. A new peak at 1719 cm-1 was observed in the FTIR spectra that can be attributed to the loss of type one amine functionality. The m/z of the proposed compound was observed in the mass spectra.Conclusion: The potential incompatibility of Methyldopa with reducing carbohydrates was established using physicochemical methods.

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Compatibility Studies of Selected Mucolytic Drugs With Excipients Used in Solid Dosage Forms: Thermogravimetry Analysis

Ramos¹

2021

FARMACIA

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The drugs except active pharmaceutical ingredient (API) contain excipients in formulations. In drugs formulations, it is important that API and excipient are compatible. As a quick and cheap method of testing the compatibility of API with an excipient, thermal methods can be used, including thermogravimetry analysis. In this study, the assessed compatibility of selected mucolytic drugs (ambroxol, bromhexine, acetylcysteine) with excipients (magnesium stearate, lactose monohydrate, starch) is used in solid dosage form. TG and DTG analysis were done for pure API, excipients, and binary mixture API/excipient with different ratio. The study has shown that the tested mucolytic drugs are compatible with magnesium stearate, but are incompatible with lactose monohydrate. The Maillard reaction is responsible for this incompatibility, which was additionally confirmed by a colorimetric method. The starch and acetylcysteine are compatible, but starch and ambroxol are incompatible. The measurements for compatibility bromhexine witch starch are ambiguous. The obtained results proved the usefulness of TG and DTG measurements for initial examination of compatibility API/excipient in preformulation studies. RezumatMedicamentele, cu excepția principiului activ (API), conțin în formulări excipienți, iar aceștia trebuie să fie compatibili. Pentru testarea compatibilității API cu un excipient, pot fi utilizate metode termice, inclusiv analize termogravimetrice. În acest studiu, evaluarea compatibilității medicamentelor mucolitice selectate (ambroxol, bromhexină și acetilcisteină) cu excipienții stearat de magneziu, lactoză monohidrat și amidon, s-a realizat pentru forme farmaceutice solide. Analiza TG și DTG s-a efectuat pentru API pur, excipienți și amestec binar API/excipient, în raport diferit. Studiul a demonstrat că substanțele mucolitice testate sunt compatibile cu stearatul de magneziu, dar sunt incompatibile cu lactoza monohidrat. Amidonul și acetilcisteina pot fi formulate împreună, în timp ce amidonul și ambroxolul s-au dovedit incompatibile. Determinările pentru stabilirea asocierii amidonului cu bromhexinul sunt neconcludente. Rezultatele obținute au dovedit utilitatea măsurătorilor TG și DTG pentru testarea inițială a compatibilității API/excipient în studiile de preformulare.

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Thermal Analysis Methods in Pharmaceutical Quality Control

Cited by 5 publications

References 19 publications

The Benefits and Challenges of Antibiotics–Non-Steroidal Anti-Inflammatory Drugs Non-Covalent Reaction

The Benefits and Challenges of Antibiotics–Non-Steroidal Anti-Inflammatory Drugs Non-Covalent Reaction

Analytical Investigation of the Possible Chemical Interaction of Methyldopa with Some Reducing Carbohydrates Used as Pharmaceutical Excipients

Compatibility Studies of Selected Mucolytic Drugs With Excipients Used in Solid Dosage Forms: Thermogravimetry Analysis

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