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Formulation Design and Characterization of Fixed-Dose Combination Preparations with Controlled Release
| DC Field | Value | Language |
|---|---|---|
| dc.contributor.advisor | 이범진 | - |
| dc.contributor.author | NGUYEN VAN HIEN | - |
| dc.date.accessioned | 2018-11-08T08:16:06Z | - |
| dc.date.available | 2018-11-08T08:16:06Z | - |
| dc.date.issued | 2016-02 | - |
| dc.identifier.other | 21575 | - |
| dc.identifier.uri | https://dspace.ajou.ac.kr/handle/2018.oak/12072 | - |
| dc.description | 학위논문(석사)--아주대학교 일반대학원 :약학,2016. 2 | - |
| dc.description.tableofcontents | 1. Introduction 4 2. Materials and Methods 11 2.1. Materials 11 2.2. Preparation of AFN 200 mg bilayered tablet 11 2.2.1. Formulation and preparation of 110 mg of AFN immediate release layer 12 2.2.2. Formulation and preparation of 90 mg of AFN sustained release layer 12 2.3. Bilayered tablet compression 13 2.4. Formulation evaluation 17 2.4.1. Micromeritic properties of lubricated granules and powder blends 17 2.4.2. Tablet assay and physical evaluation 18 2.4.3. In vitro dissolution studies 18 2.4.4. Similarity factor (f2) 19 2.4.5. Powder X-ray diffraction (PXRD) 20 2.4.6. Scanning electron microscopy (SEM) 20 2.4.7. Stability studies 21 2.5. HPLC analysis 21 3. Results and discussions 23 3.1. Micromeritic properties of lubricated granules and powder blends 23 3.2. Tablet assay and physical evaluation of AFN 110 mg immediate release tablets and AFN 200 mg bilayered tablet formulation 25 3.3. In vitro dissolution studies 27 3.3.1. AFN immediate release formulation 27 3.3.2. AFN bilayered tablet formulation 30 3.4. Characterizations of the solid states of the granules/powder blends 37 3.5. Stability study 40 4. Conclusions 44 5. References 45 Chapter II Enhanced aqueous stability of acid-labile drug EPM using alkalizer-containing solid dispersion 50 Abstract 51 1. Introduction 53 2. Materials and methods 57 2.1. Materials 57 2.2. Formulation of EPM alkalizer-containing solid dispersion 57 2.3. Preparation of EPM alkalizer-containing solid dispersion 58 2.4. In vitro stability study of EPM alkalizer-containing solid dispersion 60 2.5. Optimization of EPM solid dispersion formulations 60 2.6. Microenvironmental pH (pHM) measurement 61 2.7. Differential scanning calorimetry (DSC) 61 2.8. Powder X-ray diffraction (PXRD) 63 2.9. Fourier transform infrared spectroscopy (FT-IR) 63 2.10. Scanning electron microscopy (SEM) 64 2.11. HPLC analysis 64 3. Results and discussions 65 3.1. Screening alkalizers for stabilization of EPM in gastric fluid (pH 1.2) and intestinal fluid (pH 6.8) 65 3.2. Optimization of EPM solid dispersion formulations 66 3.3. Microenvironmental pH (pHM) measurement 69 3.4. Differential scanning calorimetry (DSC) 71 3.5. Powder X-ray diffraction (PXRD) 73 3.6. Fourier transform infrared spectroscopy (FT-IR) 73 3.7. Scanning electron microscopy (SEM) 77 4. Conclusions 80 5. References 81 | - |
| dc.language.iso | eng | - |
| dc.publisher | The Graduate School, Ajou University | - |
| dc.rights | 아주대학교 논문은 저작권에 의해 보호받습니다. | - |
| dc.title | Formulation Design and Characterization of Fixed-Dose Combination Preparations with Controlled Release | - |
| dc.title.alternative | Formulation Design and Characterization of Fixed-Dose Combination Preparations with Controlled Release | - |
| dc.type | Thesis | - |
| dc.contributor.affiliation | 아주대학교 일반대학원 | - |
| dc.contributor.department | 일반대학원 약학 | - |
| dc.date.awarded | 2016. 2 | - |
| dc.description.degree | Master | - |
| dc.identifier.localId | 739409 | - |
| dc.identifier.url | http://dcoll.ajou.ac.kr:9080/dcollection/jsp/common/DcLoOrgPer.jsp?sItemId=000000021575 | - |
| dc.subject.keyword | bilayered tablet | - |
| dc.subject.keyword | immediate release layer | - |
| dc.subject.keyword | sustained release layer | - |
| dc.subject.keyword | alkalizer | - |
| dc.subject.keyword | solid dispersion | - |
| dc.subject.keyword | drug stability | - |
| dc.description.alternativeAbstract | The aim of this study is to investigate the effect of the pharmaceutical alkalizers on the stability of EPM which is an proton-pump inhibitor (PPI) drug in gastro-intestinal fluid. The alkalizer-added solid dispersion containing EPM were prepared by dissolving (or dispersing) EPM, alkalizer, and Opadry®, in ethanol 50% followed by spray drying. Nine different alkalizers were tested for the stability enhancement of EPM assessed by in vitro stability testing in two media, gastric fluid (pH 1.2 buffer), and intestinal fluid (pH 6.8 buffer). The microenvironmental pH (pHM) was measured to elucidate the effect of alkalizer on pHM of solid dispersions. Drug crystallinity and morphology of pure drug and drug-loaded solid dispersion were examined by DSC, PXRD, and SEM. The interaction among the drug, carrier and alkalizer were clarified by FT-IR spectra. Alkalizer A8 was proved to be the best alkalizer to stabilize EPM in both gastric and intestinal fluids when incorporated in solid dispersion containing EPM. pHM of EPM alkalizer-containing solid dispersion were remarkably higher than that of non-alkalizer counterpart. The pHM value was in the decreasing order: A8, A1, A2, and no alkalizer. The DSC, PXRD data exhibited a change in EPM crystallinity in solid dispersion from crystalline to amorphous. FT-IR indicated a strong molecular interaction between EPM, alkalizer and Opadry®, especially A8 showed the strongest interaction with EPM. SEM data showed a relatively spherical shape of A8-incorporated solid dispersion compared to the obscure shape of pure drug. This study provides a promising approach for stabilization of acid-labile drug, thereby improving drug bioavailability. Key words: alkalizer, solid dispersion, microenvironmental pH (pHM), acid-labile drug, drug stability. | - |
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- Graduate School of Ajou University > Department of Pharmacy > 3. Theses(Master)
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