Čes. slov. farm. 2020, 69(1):43-47 | DOI: 10.36290/csf.2020.005
Investigation of thioctic acid, magnesium stearate and pyridoxine hydrochloride compatibility
- 1 National University of Pharmacy, Kharkiv, Ukraine
- 2 Institute for Scintillation Materials of NAS of Ukraine, Kharkiv, Ukraine
- 3 State Scientific Institution «Institute for Single Crystals», NAS of Ukraine, Kharkiv, Ukraine
To identify possible interactions of components in dosage forms, studies are usually carried out at the stage of pharmaceutical development. Such studies can predict compatibility of active pharmaceutical ingredients and excipients in order to optimize drug formulation and certain parameters of technological process. Compatibility of some components of a newly developed neuroprotective medicinal product 'Neuronucleos', namely, thioctic acid, pyridoxine hydrochloride, magnesium stearate and magnesium lactate, was studied by means of differential scanning calorimetry (DSC) and Fourier-transform infrared spectroscopy (FTIR). No interactions were observed between thioctic acid and pyridoxine hydrochloride. Formation of an intermolecular complex between thioctic acid and magnesium stearate was established, in which this acid substitutes the crystalline water of magnesium stearate. No significant interactions were found for magnesium lactate with thioctic acid or magnesium stearate. Thus, pharmaceutical compatibility of the most of the tested 'Neuronucleos' components was studied and established, with the only exception (thioctic acid with magnesium stearate). Moreover, the present study provides valuable information about thermal effects in a certain temperature range, which is important for setting the technological process parameters.
Keywords: pharmaceutical compatibility; thioctic acid; pyridoxine hydrochloride; magnesium stearate; differential scanning calorimetry; IR-spectroscopy
Received: October 7, 2019; Accepted: January 15, 2020; Published: January 1, 2020 Show citation
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