stability Dotaz Zobrazit nápovědu
Reliable stabilization of the pharmaceutical preparation and the active ingredient remains one of the most important problems of world pharmacy because pharmaceutical preparations are not systems which are stable without limitation. The patient must receive a quality drug and that is why the question of stability is paid grest attention to not only in research and development, industrial manufacture, but also in distribution. The measure of stability is the expiration period. Diluted solution of hydrogen peroxide (3% solution) still belongs to the most widely used and at the same time the most easily accessible disinfectants. In practice it is common both in Slovakia and abroad. It is used in several concentrations. One of its most important disadvantages is its limited stability, which markedly decreases its expiration period. The present paper investigates the stability of hydrogen peroxide solutions of routinely used concentrations (3%, 6%, and 10%) without and with a stabilizing additive (phenacetin) prepared in the pharmacy and stored under different conditions for the period of their expected usability. The content of hydrogen peroxide was assayed by the pharmacopoeial method in 7-day time intervals. All concentrations of 3%, 6%, and 10% hydrogen peroxide were found to fulfil the conditions for stability in the period of time under study. Their concentration did not fall below the limit od 90% of the content of the active ingredient, and storage under decreased temperature proved to be more suitable. Storage of hydrogen peroxide in the light is inadmissible. When the conditions of storage are observed, the required therapeutic effect of hydrogen peroxide solution can be expected for the period of three months.
- MeSH
- peroxid vodíku chemie MeSH
- roztoky MeSH
- skladování léků MeSH
- stabilita léku MeSH
- Publikační typ
- anglický abstrakt MeSH
- časopisecké články MeSH
- Názvy látek
- peroxid vodíku MeSH
- roztoky MeSH
- MeSH
- farmaceutická chemie MeSH
- fosfáty * MeSH
- stabilita léku MeSH
- Publikační typ
- časopisecké články MeSH
- Názvy látek
- fosfáty * MeSH
- MeSH
- dexamethason * MeSH
- masti * MeSH
- stabilita léku * MeSH
- triamcinolon * MeSH
- Publikační typ
- časopisecké články MeSH
- Názvy látek
- dexamethason * MeSH
- masti * MeSH
- triamcinolon * MeSH
- MeSH
- pyrazoly * MeSH
- rozpouštědla * MeSH
- stabilita léku * MeSH
- vysoká teplota * MeSH
- Publikační typ
- časopisecké články MeSH
- Názvy látek
- pyrazoly * MeSH
- rozpouštědla * MeSH
The preparation of an amorphous solid dispersion (ASD) is a promising strategy for improving the poor oral bioavailability of many active pharmaceutical ingredients (APIs). However, poor predictability of ASD long-term physical stability remains a prevalent problem. The purpose of this study was to evaluate and compare the predictive performance of selected models concerning solid-liquid equilibrium (SLE) curve and glass-transition temperature (Tg) line modeling of ibuprofen (IBU) in cellulosic polymers (i.e., hydroxypropyl methylcellulose (HPMC) and hydroxypropyl methylcellulose acetate succinate (HPMCAS)). For SLE curve modeling, an empiricalanalyticalapproach(Kyeremateng et al., 2014)and the Perturbed-Chain Statistical Associating Fluid Theory (PC-SAFT) equation of state (EOS) were chosen. Due to the unavailability of PC-SAFT parameters for both polymers, an approximation procedure for parametrization was applied. The Gordon-Taylor equation and Kwei equation were considered for Tg line determination. The impact of various computational set-ups (e.g., model parametrization or extrapolation length) on IBU solubility prediction at storage conditions was thoroughly investigated, assessed and confronted with the results from an 18-month physical stability study. IBU developed stable 20 wt% API content ASDs with both HPMC and HPMCAS.The extrapolation behavior and subsequent ASD thermodynamic stability prediction at storage conditions deduced from the aforementioned models weresignificantly different. Overall, the PC-SAFT EOS predicted higher IBU solubility in both polymers and, thus, a lower recrystallization tendency when compared to the empirical analytical approach. At higherIBU concentrations, liquid-liquid demixing inIBU-polymer systems was predicted by the PC-SAFT EOS, which was in qualitative disagreement with experimental observation.
- Klíčová slova
- Amorphous solid dispersion, Hot-melt extrusion, PC-SAFT, Phase diagram, Physical stability, Solid-liquid equilibrium,
- MeSH
- deriváty hypromelózy MeSH
- farmaceutická chemie * MeSH
- methylcelulosa MeSH
- pomocné látky * MeSH
- rozpustnost MeSH
- stabilita léku MeSH
- Publikační typ
- časopisecké články MeSH
- Názvy látek
- deriváty hypromelózy MeSH
- methylcelulosa MeSH
- pomocné látky * MeSH
- Klíčová slova
- CHEMISTRY, PHARMACEUTICAL *, CZECHOSLOVAKIA *, DRUG INDUSTRY *, DRUGS *, STATE MEDICINE *,
- MeSH
- farmaceutická chemie * MeSH
- farmaceutický průmysl * MeSH
- farmacie * MeSH
- léčivé přípravky * MeSH
- lidé MeSH
- stabilita léku * MeSH
- státní lékařství * MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Československo MeSH
- Názvy látek
- léčivé přípravky * MeSH
- MeSH
- azosloučeniny * MeSH
- stabilita léku * MeSH
- světlo * MeSH
- vlhkost * MeSH
- vzduch * MeSH
- Publikační typ
- časopisecké články MeSH
- Názvy látek
- azosloučeniny * MeSH
- MeSH
- peniciliny normy MeSH
- příprava léků normy MeSH
- stabilita léku MeSH
- Publikační typ
- časopisecké články MeSH
- Názvy látek
- peniciliny MeSH
- MeSH
- balení léků * MeSH
- náhražky plazmy * MeSH
- plastické hmoty MeSH
- skladování léků * MeSH
- stabilita léku * MeSH
- Publikační typ
- časopisecké články MeSH
- Názvy látek
- náhražky plazmy * MeSH
- plastické hmoty MeSH