DSC supported by factor analysis as a reliable tool for compatibility study in pharmaceutical mixtures

Rojek, Barbara; Wesołowski, Marek

doi:10.1007/s10973-019-08223-7

Cited by 19 publications

(8 citation statements)

References 15 publications

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“…This is indicative of the stability of cellulose-based biopolymers in the DDS. In the development of DDS formulations, chemical reactions can occur between active molecules and biopolymers, which is why it is important to identify the stability of the delivery system over a period of time and a range of temperature [ 40 ]. Therefore, the results indicate the stability and integrity of the nano/micro alginate delivery systems.…”

Section: Resultsmentioning

confidence: 99%

Biopolymeric Delivery Systems for Cosmetic Applications Using Chlorella vulgaris Algae and Tea Tree Essential Oil

2020

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Cosmetic products in which all the skincare compounds are biomolecules, biocompatible and biodegradable constitute a request of an educated consumer corresponding to a premium cosmetic segment. For this purpose, a cellulose-based delivery system was developed to retain biomolecules for dermic applications. The 3D matrix was built with microfibrillated cellulose, nanofibrillated cellulose and carboxymethylcellulose combined with a crosslinking agent, the alginate, to obtain a 3D matrix capable of retaining and releasing bioactive components of microalgae Chlorella vulgaris and tea tree essential oil. The porosity and pore dimensions and uniformity of this support matrix were optimized using 3D computational tools. The structures of the biopolymers were characterized using SEM, EDX, FTIR-ATR and DSC techniques. The essential oil and the microalgae components were successfully incorporated in a 3D stable matrix. The results indicate that the polymeric matrix retains and releases the essential oil biomolecules in a controlled way, when compared with tea tree essential oil, which is vaporized from 25 °C to 38 °C, without this 3D polymeric matrix. The microalgae and cellulose-based delivery system proved to be an interesting option for dermic and cosmetic applications because the exposure time of the therapeutic biomolecules was improved, and this factor consists of a competitive benefit for dermic systems.

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Section: Resultsmentioning

confidence: 99%

Biopolymeric Delivery Systems for Cosmetic Applications Using Chlorella vulgaris Algae and Tea Tree Essential Oil

2020

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“…The incompatibility of two drugs can result in the change of their physical characteristics, which can be observed as a shift in the characteristic peak temperature (±5 °C) or if the peak notably changes its shape, disappears or a new peak occurs [ 12 , 19 , 21 , 22 ]. In the provided measurements, a shift of the peak temperature was observed for SASP (9.6 °C); on the other hand, the FA characteristic melting peak did not shift notably (1.6 °C), which implies that the two drugs might be compatible.…”

Section: Resultsmentioning

confidence: 99%

Drug–Drug Compatibility Evaluation of Sulfasalazine and Folic Acid for Fixed-Dose Combination Development Using Various Analytical Tools

et al. 2021

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The simultaneous administration of sulfasalazine and folic acid is regular practice in the therapy of inflammatory bowel diseases in order to maintain sufficient folate concentration in patients. Having multiple drugs in the therapy increases the possibility of patients failing adherence, thus unintentionally endangering their health. A fixed-dose combination of sulfasalazine and folic would simplify the classical polytherapeutic approach; however, the physicochemical compatibility investigation of two active pharmaceutical ingredients plays an important role in the development of such a product. In this work, various analytical tools were used to determine the physicochemical compatibility of sulfasalazine and folic acid. For the evaluation of chemical compatibility, infrared spectroscopy in combination with advanced statistical methods, such as the principal component analysis and cluster analysis, were used, whilst a simultaneous thermogravimetry/differential thermal analysis gave us an insight into the physical compatibility of two drugs. Isothermal stress testing, forced degradation and dissolution studies, followed by the analysis with a developed chromatographic method for the monitoring of folic acid, sulfasalazine and two of its related impurities, sulfapyridine and salicylic acid, gave us an insight into its chemical compatibility. The combination of the results obtained from the used techniques implies a satisfactory physicochemical compatibility between sulfasalazine and folic acid, which opens the path to the development of the proposed fixed-dose combination.

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“…Indeed, no shifts in the Tg of travoprost occurred with varying ratios of NaHA:Travoprost. This method has been successfully used to predict the compatibility of components within pharmaceutical mixtures [40][41][42]. As no incompatibility was brought to light between travoprost and NaHA, the latter was further used in the final PFED formulation.…”

Section: Discussionmentioning

confidence: 99%

New Preservative-Free Formulation for the Enhanced Ocular Bioavailability of Prostaglandin Analogues in Glaucoma

Alviset

Corvis

Hammad³

et al. 2022

Pharmaceutics

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Glaucoma is a wide-spread eye disease caused by elevated intraocular pressure. Uncontrolled, this pressure may lead to damages to the optic nerve. Prostaglandin analogues, such as latanoprost and travoprost (which are water-insoluble active substances), are the most used class of active pharmaceutical ingredient. To administer them as eye drops, preservatives, such as benzalkonium chloride, are used as solubilizers. The latter is known to cause a local inflammation when used chronically and is not recommended for patients with ocular surface disorders. In this work, we sought to use polysorbate 80 (PS80) as a solubilizing agent simultaneously with sodium hyaluronate (NaHA) as a thickener and cytoprotective agent for the corneal surface. The first part of this study assessed the compatibility of the excipients with the active substance, using physicochemical methods such as spectra fluorescence and differential scanning calorimetry (DSC), as well as the solubilization mechanism of PS80 regarding prostaglandin analogues using nuclear magnetic resonance (NMR). The second part evaluated the stability of a formula candidate, its viscosity upon instillation, and its pharmacokinetic profile in rabbits as compared to the commercially approved medicine Travatan®. The results show that sodium hyaluronate is inert with respect to travoprost, while PS80 successfully solubilizes it, meaning that benzalkonium chloride is no longer required. Moreover, the pharmacokinetic profiles of the rabbits showed that the original formula described in the present study enhanced the ocular bioavailability of the drug, making it a promising product to control intraocular pressure with a potential reduced dosage of travoprost, therefore minimizing its related side effects.

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DSC supported by factor analysis as a reliable tool for compatibility study in pharmaceutical mixtures

Cited by 19 publications

References 15 publications

Biopolymeric Delivery Systems for Cosmetic Applications Using Chlorella vulgaris Algae and Tea Tree Essential Oil

Biopolymeric Delivery Systems for Cosmetic Applications Using Chlorella vulgaris Algae and Tea Tree Essential Oil

Drug–Drug Compatibility Evaluation of Sulfasalazine and Folic Acid for Fixed-Dose Combination Development Using Various Analytical Tools

New Preservative-Free Formulation for the Enhanced Ocular Bioavailability of Prostaglandin Analogues in Glaucoma

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