Excipient compatibility as assessed by isothermal microcalorimetry

Phipps, Mark A.; Winnike, Richard A.; Long, Stacey T.; Viscomi, Frank

doi:10.1111/j.2042-7158.1998.tb02209.x

Cited by 14 publications

(2 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Spectroscopic and thermal techniques are frequently used for incompatibility studies between drugs and excipients [15][16][17][18][19][20][21][22][23][24][25]. Spectroscopic techniques are sensitive to the structure, functional groups and environment of organic compounds.…”

Section: Gereç Vementioning

confidence: 99%

Drug-Excipient Compatibility Studies In Binary Mixtures of Tadalafil by Using DSC, TGA and FTIR

Doğantürk

Canbay

2023

Süleyman Demirel Üniversitesi Sağlık Bilimleri Dergisi

View full text Add to dashboard Cite

Objective: During drug preformulation studies, thermal analysis and spectroscopic techniques are used to detect physical or chemical incompatibilities between the active compound and the excipients in the formulation, and to demonstrate the safety and/or efficacy of the final product. It has revolutionized erectile dysfunction with the development of a selective cyclic guanosine monophosphate-specific PDE-5 inhibitors. Tadalafil is one of these inhibitors. Excipients are included in dosage forms to assist in manufacture, absorption or application. Although considered to be pharmacologically inert, the drug active compound may impair effectiveness. Material and Method: DSC, TGA, and FTIR, were used in the work. Ascorbic acid, butylated hydroxyanisole, calcium phosphate dibasic, cellulose, magnesium stearate, mannitol, sodium carboxymethyl cellulose, sucrose, talc, starch, primojel, and citric acid exhibit interaction with Tadalafil. Binary mixtures of drug:excipient have been analyzed. Results: Based on spectroscopic and thermal results; Tadalafil is incompatible with magnesium stearate, mannitol, sucrose, and ascorbic acid. Conclusion: Studies to investigate drug-excipient compatibility are an important step in drug development studies. Thermal and spectroscopic techniques are widely used in such studies.

show abstract

Section: Gereç Vementioning

confidence: 99%

Drug-Excipient Compatibility Studies In Binary Mixtures of Tadalafil by Using DSC, TGA and FTIR

Doğantürk

Canbay

2023

Süleyman Demirel Üniversitesi Sağlık Bilimleri Dergisi

View full text Add to dashboard Cite

show abstract

“…A similar approach can be adopted for testing binary mixtures of API and excipient [12][13]; the thermal behaviour, under a controlled relative humidity (for example, 75%), of the active alone and the excipient alone are recorded and compared with that determined for a binary drug-excipient mixture. Any unexpected heat-flows recorded in the drug-excipient mixture indicate a possible interaction.…”

Section: Primary Screeningmentioning

confidence: 99%

Stability Assessment of Pharmaceuticals and Biopharmaceuticals by Isothermal Calorimetry

Gaisford¹

2005

CPB

View full text Add to dashboard Cite

The assessment of stability (of actives, excipients and/or formulated products) is an important, and often time-consuming, part of pharmaceutical product development. Conventionally, HPLC is used to quantify the concentrations of a parent compound and any degradation products as a function of storage time. HPLC, however, is relatively insensitive to small changes in concentration and it is often the case that stability assays are conducted under stress conditions, in order to accelerate any degradation processes. The Arrhenius relationship is then employed to give an initial prediction of stability under storage conditions while long-term studies, under storage conditions, are conducted to confirm these predictions. The properties of isothermal calorimetry, such as its intrinsic sensitivity to small changes in heat and invariance to the physical form of a sample, make it ideally suited for stability assessment because it obviates the need for an Arrhenius analysis. In addition, the ability to conduct titration or gas perfusion experiments vastly increases its range of applications. Recent advances in instrumental design and data analysis have made it easier to analyse data quantitatively for complex systems. It is the purpose of this review to highlight some of these developments, discuss them in the context of pharmaceutical and biopharmaceutical examples and explore some of the future challenges and applications of the technique.

show abstract

Isothermal Calorimetric Analysis

Hills

2011

Solid State Characterization of Pharmaceuticals

View full text Add to dashboard Cite

Excipient compatibility as assessed by isothermal microcalorimetry

Cited by 14 publications

References 0 publications

Drug-Excipient Compatibility Studies In Binary Mixtures of Tadalafil by Using DSC, TGA and FTIR

Drug-Excipient Compatibility Studies In Binary Mixtures of Tadalafil by Using DSC, TGA and FTIR

Stability Assessment of Pharmaceuticals and Biopharmaceuticals by Isothermal Calorimetry

Isothermal Calorimetric Analysis

Contact Info

Product

Resources

About