دورية أكاديمية
Hot-melt mixing of partially miscible active pharmaceutical ingredient-polymer mixtures
| العنوان: | Hot-melt mixing of partially miscible active pharmaceutical ingredient-polymer mixtures |
|---|---|
| المؤلفون: | Yang, Min |
| المصدر: | Dissertations |
| بيانات النشر: | Digital Commons @ NJIT |
| سنة النشر: | 2012 |
| المجموعة: | Digital Commons @ New Jersey Institute of Technology (NJIT) |
| مصطلحات موضوعية: | Solubility, Hot-melt extrusion, Rheology, Crystallization, Poly(ethylene oxide), Acetaminophen, Chemical Engineering |
| الوصف: | Solid dispersion/solution processes for producing pharmaceutical oral dosages such as hot-met extrusion (HME) have received increasing attention by industry and academe because they can enhance drugs’ solubility and even bioavailability to a great extent by converting drugs from crystalline to amorphous form. HME can be carried out at two process temperature regimes: one where Tprocess > Tm of the drug and the Tg of the polymer (or the Tm for the case of semi-crystalline polymers); the other at Tm > Tprocess > Tg (Tm for the case of semi-crystalline polymer). Processing below the drug’s melting point in the second case has the advantage of reducing potential for degradation. Broader applications of HME are often limited by two technical challenges. One is that the active pharmaceutical ingredient (API) or the polymer may degrade at the elevated temperatures during extrusion processing. To avoid this problem and yet obtain a well-mixed solid dispersion/solution, HME needs to be carried out in an optimal processing window, where the temperature is kept safely below the degradation temperature but is high enough to enhance API’s dissolution in the polymer. Another challenge is the possible physical instability of the extrudate during its shelf life. The API’s solubility is decreased significantly once the temperature is dropped from the HME processing temperature to room temperature. As a result, the drug may recrystallize from the polymeric matrix. It is rather challenging to experimentally determine the API’s solubility in the polymer and there are only few published articles in this area. In this dissertation, solid dispersions of a model drug acetaminophen (APAP) and a pharmaceutical grade polymer poly(ethylene oxide) (PEO) were prepared by using hot- melt mixing (HMM), a process closely related to HME. APAP’s solubility in PEO at HME processing temperature was measured utilizing a novel rheological characterization technique, hot-stage microscopy and differential scanning calorimetry (DSC). The ... |
| نوع الوثيقة: | text |
| وصف الملف: | application/pdf |
| اللغة: | unknown |
| العلاقة: | https://digitalcommons.njit.edu/dissertations/336Test; https://digitalcommons.njit.edu/cgi/viewcontent.cgi?article=1391&context=dissertationsTest |
| الإتاحة: | https://digitalcommons.njit.edu/dissertations/336Test https://digitalcommons.njit.edu/cgi/viewcontent.cgi?article=1391&context=dissertationsTest |
| رقم الانضمام: | edsbas.A74D2DA1 |
| قاعدة البيانات: | BASE |
| الوصف غير متاح. |