Formulation and optimization of anticlotting drug in certain drug delivery system / (Record no. 177298)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 08512namaa22004451i 4500 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | EG-GICUC |
| 005 - أخر تعامل مع التسجيلة | |
| control field | 20260102143550.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 260102s2025 ua a|||frm||| 000 0 eng d |
| 040 ## - CATALOGING SOURCE | |
| Original cataloguing agency | EG-GICUC |
| Language of cataloging | eng |
| Transcribing agency | EG-GICUC |
| Modifying agency | EG-GICUC |
| Description conventions | rda |
| 041 0# - LANGUAGE CODE | |
| Language code of text/sound track or separate title | eng |
| Language code of summary or abstract | eng |
| -- | ara |
| 049 ## - Acquisition Source | |
| Acquisition Source | Deposit |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 615.1 |
| 092 ## - LOCALLY ASSIGNED DEWEY CALL NUMBER (OCLC) | |
| Classification number | 615.1 |
| Edition number | 21 |
| 097 ## - Degree | |
| Degree | Ph.D |
| 099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC) | |
| Local Call Number | Cai01.08.08.Ph.D.2025.Ma.F |
| 100 0# - MAIN ENTRY--PERSONAL NAME | |
| Authority record control number or standard number | Mahmoud Mostafa Ahmed, |
| Preparation | preparation. |
| 245 10 - TITLE STATEMENT | |
| Title | Formulation and optimization of anticlotting drug in certain drug delivery system / |
| Statement of responsibility, etc. | by Mahmoud Mostafa Ahmed ; Supervision Prof. Dr. Mohamed Ahmed El-Nabarawi, Prof. Dr. Mahmoud Hassan Teaima, Dr. Mohammed Yasser Hamdy. |
| 246 15 - VARYING FORM OF TITLE | |
| Title proper/short title | صياغة وتعظيم عقار مضاد لتجلط الدم في نظام توصيل دوائي معين |
| 264 #0 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE | |
| Date of production, publication, distribution, manufacture, or copyright notice | 2025. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 112 pages : |
| Other physical details | illustrations ; |
| Dimensions | 25 cm. + |
| Accompanying material | CD. |
| 336 ## - CONTENT TYPE | |
| Content type term | text |
| Source | rda content |
| 337 ## - MEDIA TYPE | |
| Media type term | Unmediated |
| Source | rdamedia |
| 338 ## - CARRIER TYPE | |
| Carrier type term | volume |
| Source | rdacarrier |
| 502 ## - DISSERTATION NOTE | |
| Dissertation note | Thesis (Ph.D)-Cairo University, 2025. |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE | |
| Bibliography, etc. note | Bibliography: pages 105-112. |
| 520 #3 - SUMMARY, ETC. | |
| Summary, etc. | Acute Coronary Syndrome necessitates Dual Antiplatelet Therapy with aspirin and a <br/>P2Y12 inhibitor (e.g., ticagrelor) to prevent recurrent cardiovascular events. Existing <br/>regimens require multiple tablets, reducing patient compliance. This study developed a <br/>single-dose multilayer tablet, physically separating ticagrelor and aspirin, using an <br/>intermediate layer to prevent degradation while optimizing critical quality attributes. <br/>Chapter 1: Formulation and Pre-compression evaluation of a single-dose <br/>combination of ticagrelor and aspirin for dual antiplatelet therapy: <br/>The development of ticagrelor/aspirin multilayer tablets (TG/ASP MLTs) began with <br/>critical pre-formulation studies. Differential scanning calorimetry (DSC) revealed <br/>chemical incompatibility between ticagrelor and aspirin, evidenced by a new <br/>endothermic peak at 105.68°C in their physical mixture. This finding necessitated a <br/>separation strategy, leading to a three-layer design: a ticagrelor layer (TG), an inert <br/>middle layer (MID), and an aspirin layer (ASP). To enhance ticagrelor’s solubility, a <br/>self-micro emulsifying drug delivery system (SMEDDS) was developed using glyceryl <br/>monocaprylate, Cremophor RH 40, and PEG 400, solidified with microcrystalline <br/>cellulose. Powder blends for all layers exhibited excellent flow and compressibility <br/>properties (angle of repose: 28.3°–35.4°; Carr’s index: 10.7–14.6%), attributed to talc’s <br/>role in reducing interparticulate friction and silicon dioxide’s cohesion-enhancing <br/>effects. A 3² factorial design (Design-Expert® 12) was employed, evaluating two <br/>categorical variables: disintegrant type in TG layer (sodium starch glycolate/SSG, <br/>croscarmellose sodium/CCS, pregelatinized starch/PS) and disintegrant type in ASP <br/>layer (same options). <br/>Chapter 2: Formulation, post-compression evaluation and optimization of <br/>ticagrelor/aspirin multi-layer tablets: <br/>Nine formulations (F1-F9) were compressed into 700 mg oval biconcave tablets using <br/>direct compression. Post-compression analysis confirmed pharmacopeial compliance: <br/>- Hardness: 6.7–8.9 kp <br/>- Friability: <0.6% <br/>- Drug content: 92.56–100.52% (ASP), 95.52–100.52% (TG) <br/>- Disintegration time: 122–152 seconds <br/>@ Formulation and optimization of anticlotting Drug in certain drug delivery system <br/>- Ticagrelor release (30 min): 79–91% <br/>Factorial analysis revealed: <br/>- TG-layer disintegrant significantly impacted all responses (p<0.05): CCS yielded <br/>fastest disintegration (122 s) and highest drug release (90.77%) but lower hardness. <br/>PS provided superior hardness but slower release. <br/>- ASP-layer disintegrant showed negligible effects (p>0.05). <br/>Optimization identified F5 (CCS in TG layer; PS in ASP layer) as ideal, achieving: <br/>- Hardness: 7.30 ± 0.37 kp <br/>- Disintegration: 122 ± 3.3 s <br/>- Drug release: 90.77% at 30 min <br/>- Desirability score: 0.873 <br/>Accelerated stability testing (40°C/75% RH, 3 months in Alu-Alu blisters) showed: <br/>- Minimal changes in weight, thickness, and hardness <br/>- Aspirin content reduction: <3.5% <br/>- Disintegration time and drug release remained consistent <br/>Stability was attributed to moisture-protective excipients (talc), minimal magnesium <br/>stearate (0.5%), and robust packaging. <br/>Chapter 3: In vivo evaluation of the antithrombotic effect of ticagrelor/aspirin <br/>multi-layer tablets, using rabbit cuticle bleeding time method: <br/>The antithrombotic effect of optimized F5 was validated in rabbits (n=6/group) using <br/>cuticle bleeding time (BT) method: <br/>- Control (no treatment): 4.08 ± 1.06 min <br/>- F5 (single MLT): 9.90 ± 0.89 min (p<0.05 vs. control) <br/>- Commercial DAPT (separate tablets): 11.03 ± 1.22 min (p=0.12 vs. F5) <br/>The statistically equivalent BT prolongation (p=0.12) confirmed F5’s bioequivalence <br/>to conventional dual therapy. This demonstrated: <br/>1. Successful absorption of both APIs from the MLT <br/>2. Effective P2Y12 inhibition (ticagrelor) and COX-1 suppression (aspirin) <br/>3. Clinical potential to replace multi-tablet regimens |
| 520 #3 - SUMMARY, ETC. | |
| Summary, etc. | يستخدم نظام العلاج الثنائي المضاد للصفائح الدموية في علاج متلازمة الشريان التاجي الحادة. تهدف هذه الدراسة إلى استكشاف إمكانية دمج دواء تيكاجريلور والأسبرين في قرص واحد يُتناول بجرعة واحدة كبديل عن النظام التقليدي متعدد الجرعات. تم استخدام تصميم عاملي (3²) لتطوير قرص متعدد الطبقات، يحتوي على كل دواء في طبقة منفصلة. وركّز التصميم على عاملين مستقلين، كل منهما بثلاث مستويات: نوع المفكك المستخدم في طبقة تيكاجريلور ونوع المفكك في طبقة الأسبرين. تم تحليل تأثير هذه العوامل على ثلاث استجابات معتمدة: صلابة القرص، وقت التفكك، والتحرر الدوائي. وقد استُخدم برنامج Design-Expert في تصميم التجربة وتحليل البيانات وتحسين التركيبة. تم تحديد التركيبة المثلى (F5)، والتي تضمنت استخدام كروسكارميلوز الصوديوم كمفكك في طبقة تيكاجريلور، وبريجيلاتينايزد ستارش كمفكك في طبقة الأسبرين. أظهرت هذه التركيبة صلابة قرص قدرها 7.30 ± 0.37 كيلو بوند، ووقت تفكك قدره 122 ± 3.3 ثانية، وتحررًا دوائيًا بنسبة 90.77% خلال 30 دقيقة، محققة درجة ملاءمة بلغت 0.873. كما أثبتت التركيبة استقرارها لمدة ثلاثة أشهر عند درجة حرارة 40° مئوية ورطوبة نسبية تبلغ 75%. أظهرت الاختبارات الحية باستخدام طريقة قياس وقت النزيف من جلد الأرانب زيادة ملحوظة في وقت النزيف، مماثلة لما يُسجل باستخدام النظام التقليدي متعدد الجرعات. تشير هذه النتائج إلى أن هذا القرص بجرعة واحدة قد يمثل بديلًا واعدًا وفعالًا من حيث التكلفة، معززًا لامتثال المرضى للعلاج في حالات متلازمة الشريان التاجي الحادة |
| 530 ## - ADDITIONAL PHYSICAL FORM AVAILABLE NOTE | |
| Issues CD | Issues also as CD. |
| 546 ## - LANGUAGE NOTE | |
| Text Language | Text in English and abstract in Arabic & English. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Pharmaceutics |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | علم الأدوية |
| 653 #0 - INDEX TERM--UNCONTROLLED | |
| Uncontrolled term | Bilayer |
| -- | Compression |
| -- | Drug delivery system(s) |
| -- | Drug-drug interaction(s) |
| -- | Excipient(s) |
| -- | Factorial design |
| -- | Oral drug delivery |
| -- | Stability |
| -- | Tablet(s) |
| -- | متلازمة الشريان التاجي الحادة |
| -- | العلاج المزدوج المضاد للتجلط |
| 700 0# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Mohamed Ahmed El-Nabarawi |
| Relator term | thesis advisor. |
| 700 0# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Mahmoud Hassan Teaima |
| Relator term | thesis advisor. |
| 700 0# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Mohammed Yasser Hamdy |
| Relator term | thesis advisor. |
| 900 ## - Thesis Information | |
| Grant date | 01-01-2025 |
| Supervisory body | Mohamed Ahmed El-Nabarawi |
| -- | Mahmoud Hassan Teaima |
| -- | Mohammed Yasser Hamdy |
| Universities | Cairo University |
| Faculties | Faculty of Pharmacy |
| Department | Department of Pharmaceutics |
| 905 ## - Cataloger and Reviser Names | |
| Cataloger Name | Shimaa |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Source of classification or shelving scheme | Dewey Decimal Classification |
| Suppress in OPAC | No |
| Koha item type | Thesis |
| Edition | 21 |
| Source of classification or shelving scheme | Home library | Current library | Date acquired | Inventory number | Full call number | Barcode | Date last seen | Effective from | Koha item type |
|---|---|---|---|---|---|---|---|---|---|
| Dewey Decimal Classification | المكتبة المركزبة الجديدة - جامعة القاهرة | قاعة الرسائل الجامعية - الدور الاول | 02.01.2026 | 93021 | Cai01.08.08.Ph.D.2025.Ma.F | 01010110093021000 | 02.01.2026 | 02.01.2026 | Thesis |