Quality Evaluation of Pharmaceutical Formulations  Containing Hydrochlorothiazide

Oliveira, Marcos Antônio de; Yoshida, María Irene; Silva, Daphne Carina Gonçalves Monteiro da

doi:10.3390/molecules191016824

Cited by 10 publications

(6 citation statements)

References 8 publications

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“…The thermal behaviour of LAURYL is shown in Figure S2 in the supplementary materials. We observed peaks near 200 °C and 260 °C, which agreed with the results of previous studies [46,47]. The event at 95 °C may have been due to the presence of water.…”

Section: Resultssupporting

confidence: 92%

Solid-State Characterization and Compatibility Studies of Penciclovir, Lysine Hydrochloride, and Pharmaceutical Excipients

et al. 2019

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The physical and chemical characterization of the solid-state properties of drugs and excipients is fundamental for planning new formulations and developing new strategies for the treatment of diseases. Techniques such as differential scanning calorimetry, thermogravimetry, X-ray powder diffraction, Fourier transform infrared spectroscopy, and scanning electron microscopy are among the most commonly used techniques for these purposes. Penciclovir and lysine are individually used to treat the herpes virus. As such, the development of a formulation containing both drugs may have therapeutic potential. Solid-state characterization showed that both penciclovir and lysine were crystalline materials with melting points at 278.27 °C and 260.91 °C, respectively. Compatibility studies of penciclovir and lysine indicated a possible interaction between these substances, as evidenced by a single melting point at 253.10 °C. The compatibility of several excipients, including ethylenediaminetetraacetic acid, cetostearyl alcohol, sodium lauryl sulphate, di-tert-butyl methyl phenol, liquid petrolatum, methylparaben, nonionic wax, paraffin, propylene glycol, and propylparaben, was evaluated in ternary (penciclovir-lysine-excipient) mixtures (1:1:1, w/w/w) to determine the optimal formulation. The developed formulation was stable under accelerated and ambient conditions, which demonstrated that the interaction between penciclovir and lysine was suitable for the development of a formulation containing both drugs.

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Section: Resultssupporting

confidence: 92%

Solid-State Characterization and Compatibility Studies of Penciclovir, Lysine Hydrochloride, and Pharmaceutical Excipients

et al. 2019

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“…DSC should be the first choice method to design and optimize a lyophilization cycle, due to its capability to provide a means of characterizing thermo physical properties which aid in the establishment of lyophilization process parameters [3,17,35,44]. However, above all this, DSC is well known as a rapid screening technique for testing the physical-chemical interactions between components of a formulation, starting from the fact that the successful formulation of a stable and effective dosage form depends on careful selection of the excipients in the preformulation stage [6,10,12,13,22,28,29,37,38,43,45,46]. The DSC compatibility between the components of a pharmaceutical formulation is usually evaluated on the binary mixture of two components, the interaction being represented by a shift in the melting point, changes in the peak shape or area, the development of a new transition comparing to those observed in the initial thermograms, the increase or decrease in the number of peaks due to the mixture of components [12].…”

Section: Introductionmentioning

confidence: 99%

Development of Meloxicam Oral Lyophilisates: Role of Thermal Analysis and Complementary Techniques

Rus¹

2019

FARMACIA

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The purpose of this study was to highlight the way in which thermoanalytical and complementary techniques can guide the development of meloxicam oral lyophilisates both in the preformulation and formulation stages, as well as for the final products characterization. Thermoanalytical methods (differential scanning calorimetry -DSC, thermogravimetry -TGA) and complementary methods (Fourier transform infrared -FTIR, X-Ray powder diffraction -XRPD, scanning electron microscopy -SEM) were applied in order to obtain a complete set of data. In the preformulation stage, the compatibility between meloxicam and excipients was assessed. DSC results showed the compatibility between meloxicam and excipients. Tg' measurement in the frozen state led to the addition of an annealing step at -25°C into the freezing stage, to facilitate complete crystallization and end-product integrity. The designed lyophilization cycle yielded good cake appearance. The DSC, XRPD analysis as well as SEM morphology studies, performed in the final stage, evidenced that the meloxicam freezedried products were partially crystalline. By the TGA analysis the moisture content was evaluated in accordance or close to the recommended limits. In conclusion, thermoanalytical techniques are well suited for the design of freeze-drying process, in order to obtain good quality oral lyophilisates. RezumatScopul acestui studiu a fost acela de a evidenția felul în care tehnicile de analiză termică și unele tehnici complementare pot ghida procesul de dezvoltare a liofilizatelor orale cu meloxicam, atât în etapele de preformulare și formulare, cât și pentru caracterizarea produselor finale. Metodele termice de analiză (analiza calorimetrică diferențială -DSC, analiza termogravimetrică -TGA) și cele complementare (spectroscopia în infraroșu cu transformantă Fourier -FTIR, difracția de raze X -XRPD, microscopia electronică de baleiaj -SEM) au fost aplicate pentru obținerea unui set complet de date. Astfel, în etapa de preformulare a fost studiată compatibilitatea dintre meloxicam și excipienții aleși. Rezultatele DSC au arătat existența compatibilității dintre aceștia. Determinarea Tg' în faza de înghețare a liofilizării a dus la includerea unui tratament termic la -25°C, cu scopul de a asigura structura cristalină și integritatea produsului final. Ciclul de liofilizare astfel optimizat a dus la obținerea unor liofilizate orale corespunzătoare vizual. Designul ciclului de liofilizare a fost realizat pornind de la datele DSC înregistrate, care au evidențiat temperaturile critice asociate diferitelor caracteristici fizice ale materialelor în starea înghețată. Analizele DSC, XRPD precum și studiile de morfologie SEM efectuate în etapa finală, au evidențiat faptul că liofilizatele orale cu meloxicam obținute au fost parțial cristaline. Prin metoda TGA s-a determinat conținutul acestora în umiditate, rezultatele înregistrate fiind în concordanță sau aproape de limitele recomandate. În concluzie, tehnicile de analiză termică sunt foarte potrivite pentru designul procesului de...

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“…For assessment and comparison, the dissolution profile was evaluated on the basis of the dissolution efficiency parameter (DE) which is a model-independent parameter [19].…”

Section: In-vitro Dissolution Studiesmentioning

confidence: 99%

Enhancement of Loratadine Dissolution by Surface Solid Dispersion: The Potential Use of Co-Processed Excipients as on-Surface Carriers

et al. 2022

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Objective: The aim of the work in this study is to enhance the dissolution rate of the poorly water-soluble drug; loratadine employing co-precipitated surface solid dispersions (SSDs) prepared using various hydrophilic on-surface carriers namely; Pearlitol® flash, Parteck® ODT, Prosolv® ODT G2 and Pharmaburst® C1. Methods: Loratadine solid dispersions (SDs) were prepared by co-precipitation method using copovidone, poloxamer 188 and gluconolactone at different ratios. The best formulae were selected, based on dissolution results obtained, to prepare 16 different SSDs. The prepared SSDs were subjected to drug content and in-vitro dissolution studies and the best formulae were further subjected to solid-state characterization, using X-ray powder diffraction (XRPD) and differential scanning calorimeter (DSC). The effect of aging on the best formulae was studied by evaluating the drug content, drug dissolution and the change in the crystalline state using (XRPD). Results: S1 formula, containing drug: poloxamer 188: pearlitol flash at 1:4:1 ratio, and S9 formula, containing drug: poloxamer 188: prosolv ODT at 1:4:1 ratio showed the highest dissolution efficiency. XRPD and DSC studies of S1 and S9 proved a decrease in drug crystallinity and confirmed solid dispersion formation. The stability study of S1 and S9 showed a slight reduction in the dissolution efficiency (DE) of S1 (from 84.6±0.8 to 81.4±0.7 and 81.4±1.3 at ambient and accelerated conditions, respectively) and a higher reduction in DE of S9 (from 83.5±2.4 to 69.6±1.0 and 57.3±2.9 at ambient and accelerated conditions respectively). Conclusion: Results obtained obviously confirmed the potential effect of the surface solid dispersion technique, using poloxamer 188 as a hydrophilic carrier and Pearlitol flash as an on-surface carrier, on improving the dissolution of loratadine.

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Quality Evaluation of Pharmaceutical Formulations Containing Hydrochlorothiazide

Cited by 10 publications

References 8 publications

Solid-State Characterization and Compatibility Studies of Penciclovir, Lysine Hydrochloride, and Pharmaceutical Excipients

Solid-State Characterization and Compatibility Studies of Penciclovir, Lysine Hydrochloride, and Pharmaceutical Excipients

Development of Meloxicam Oral Lyophilisates: Role of Thermal Analysis and Complementary Techniques

Enhancement of Loratadine Dissolution by Surface Solid Dispersion: The Potential Use of Co-Processed Excipients as on-Surface Carriers

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