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Characterisation of a novel, multifunctional, co-processed excipient and its effect on release profile of paracetamol from tablets prepared by direct compression

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Asian Pacific Journal of Tropical Biomedicine 2015年第9期5卷 739-742页

作者： Eraga Sylvester Okhuelegbe Arhewoh Matthew Ikhuoria Uhumwangho Michael Uwumagbe Iwuagwu Magnus Amara Department of Pharmaceutics and Pharmaceutical Technology Faculty of Pharmacy University of Benin

Objective: To characterise a novel multifunctional pharmaceutical excipient and investigate its ef ect on paracetamol release from tablets prepared by direct ***: The excipient was prepared by co-processing gelatinized maize starch with sodium carboxymethyl cellulose and microcrystalline cellulose in a ratio of 2:1:1, dried and pulverized into powder. The excipient formulated was characterized using Fourier transform infrared spectroscopy and dif erential scanning calorimetry. The excipient was used to prepare batches of tablets by direct compression with drug-excipient ratios of 1:1, 1:2, 1:3 and 1:4. Parameters evaluated on tablets include crushing strength, friability and in vitro dissolution studies. Results: Differential scanning calorimetry analysis revealed a crystalline excipient while Fourier transform infrared spectroscopy showed no interaction between the excipient and paracetamol. Tablets from all the batches gave average crushing strength values between 3.47 and 4.88 kp. The 1:1 and 1:2 tablet batches were comparable to each other while 1:3 and 1:4 were also comparable to one another in their dissolution proi les. The dissolution parameters of the 1:4 batch was faster with- m∞(90.5%), t50%(3.5 min), t70%(11.6 min) while that of ratio 1:1 was the least with- m∞(48.6%), m5min(23.8%). Their release kinetics followed a KorsmeyerPeppas model with a super case-II transport ***: The drug-excipient ratios of 1:3 and 1:4 gave pharmaceutically acceptable tablets that met the British Pharmacopoeia specii cations. The t50% value of the 1:4 batch of tablets may i nd its usefulness in formulating drugs for which a fast onset of action is desired.

关键词： Co-processed excipient Dissolution proiles Paracetamol tablet Direct compression

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Azocalixarenes: a scaffold of universal excipients with high efficiency

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Science China Chemistry 2024年第5期67卷 1697-1706页

作者： Yu-Xin Yue Yi-Lin Lin Meng-Meng Chen Han-Wen Tian Rong Ma Ze-Han Wang Fang-Yuan Chen Yu-Chen Pan Dong-Sheng Guo College of Chemistry State Key Laboratory of Elemento-Organic ChemistryKey Laboratory of Functional Polymer Materials(Ministry of Education)Frontiers Science Center for New Organic MatterCollaborative Innovation Center of Chemical Science and Engineering(Tianjin)Nankai UniversityTianjin 300071China

excipients are important components of pharmaceutical preparations that affect their quality, safety, and efficacy. Macrocyclic receptors are a family of supramolecular excipients with several advantages, including molecular-level protection, small sizes,fast kinetics of host-guest recognition, and modular construction. With the continuous advances in the medical field, personalized and precision medicine requires the development of excipients with low dosages, integrated modifying effects, universality,and controlled release. To meet these requirements, we have developed a new family of macrocyclic excipients based on calixarenes by integrating their covalent(broad chemical design space) and noncovalent(wide range of substrates) ***, azocalixarenes(Azo CAs) were designed, showing high binding affinities to a broad spectrum of active pharmaceutical ingredients(APIs), selectivity to interferents, and responsiveness to hypoxic microenvironments. Due to their highly efficient and controllable recognition, Azo CAs serve as low-dose excipients for 30 APIs. Molecular encapsulation by Azo CAs results in the integrated modification of the physicochemical properties of APIs, including solubility, stability, bioavailability,and biocompatibility. Moreover, Azo CAs can be reduced by azoreductases overexpressed in hypoxic microenvironments,leading to the controlled release of APIs. Collectively, Azo CA excipients have broad application prospects for a series of diseases such as enteritis, arthritis, stroke, cancer, bacterial infection and kidney injury, with diverse therapeutic modalities,including chemotherapy, photodynamic therapy, photothermal therapy, immunotherapy, boron neutron capture therapy, radiotherapy, fluorescence imaging, and their combinations.

关键词： supramolecular chemistry host-guest systems excipient calixarene molecular recognition

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Effect of excipients on Stability and Structure of rhCuZn-SOD Encapsulated in PLGA Microspheres

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Chemical Research in Chinese Universities 2004年第3期20卷 323-327页

作者： LIU Ling 1,2 ,GE Yu 1 and YUAN Qin-sheng 1 1. State Key Laboratory of Bioreactor Engineering and Institute of Biochemistry,East China University of Science and Technology,Shanghai 200237,P. R. China 2. Public Health School,Nanjing Medical University,Nanjing 210029,P. R. China State Key Laboratory of Bioreactor Engineering and Institute of Biochemistry East China University of Science and Technology 生物反应器工程国家重点实验室上海 200237

When a protein is encapsulated into poly( DL -lactide-co-glycolide)(PLGA) microspheres by means of the double-emulsion method,the harsh microspheres formation process including ultrasonification,exposure to an organic solvent and a polymer may cause the denaturation of the protein. In this study,we investigated the enzymatic activity change and the effect of the excipients on the stability of recombinant human Cu,Zn-superoxide dismutase(rhCu,Zn-SOD) during the emulsification. The specific activity recovery was found to be concentration dependent and the excipients involved such as PEG 600 and Tween 20,and trehalose were shown to increase the stability of rhCu,Zn-SOD. The protein structural integrity within the microspheres was analyzed by FTIR. The structure of rhCu,Zn-SOD within PLGA microspheres containing trehalose was found to be similar to that of the native solid state,whereas the protein encapsulated during the preparation in the absence of any excipient changed due to the possible hydrophobic interaction with the polymer. The results suggest that a rational stability strategy for protein to be encapsulated into microspheres should aim at different processes.

关键词： Poly( DL -lactide-co-glycolide)(PLGA) microsphere Recombinant human Cu Zn-superoxide dismutase(rhCu Zn-SOD) Fourier transform infrared(FTIR) spectroscopy Protein stability excipient

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Effects of particle size on the triboelectrification phenomenon in pharmaceutical excipients:Experiments and multi-scale modeling

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Asian Journal of Pharmaceutical Sciences 2016年第5期11卷 603-617页

作者： Raj Mukherjee Vipul Gupta Shivangi Naik Saurabh Sarkar Vinit Sharma Prasad Peri Bodhisattwa Chaudhuri Department of Pharmaceutical Sciences University of ConnecticutStorrsCT 06269USA Institute of Material Sciences University of ConnecticutStorrsCT 06269USA Merck Sharp and Dohme West PointPA 19486USA

Particle sizes play a major role to mediate charge transfer, both between identical and different material surfaces. The study probes into the probable mechanism that actuates opposite polarities between two different size fractions of the same material by analyzing the charge transfer patterns of two different sizes of microcrystalline cellulose(MCC). Quantum scale calculations confirmed alteration of charge transfer capacities due to variation of moisture content predicted by multiple surface and bulk analytical techniques. Discrete Element Method(DEM) based multi-scale computational models pertinent to predict charge transfer capacities were further implemented, and the results were in accordance to the experimental charge profiles.

关键词： Tribocharging Work function excipient Discrete Element Modeling

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Semi-solid materials for controlled release drug formulation： current status and future prospects

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Frontiers of Chemical Science and Engineering 2014年第2期8卷 225-232页

作者： Michelle TRAN Chun WANG Department of Biomedical Engineering University of Minnesota 7-105 Hasselmo Hall 312 Church Street S.E. Minneapolis MN 55455 USA

Semi-solid materials represent an important category of inactive ingredients （excipients） of pharmaceutical products. Here we review several common semisolid polymers currently used in the controlled release formulations of many drugs. These polymers are selected based on their importance and broad scope of application in FDA-approved drug products and include several polysaccharides （cellulose, starch, chitosan, alginate） and carbomers, a group of mucoadhesive synthetic polymers. Glyceride-based polymers used in self-emulsifying drug delivery systems （SEDDS） will also be discussed for its importance in formulating poorly water-soluble drugs. Unique features and advantages of each type of semi-solid materials are discussed and examples of their use in oral delivery of drugs are provided. Finally, future prospects of developing new and better semi-solid excipients are discussed with the objective of facilitating clinical translation.

关键词： semi-solids polymer excipient controlledrelease drug delivery

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Nano-enabled agglomerates and compact:Design aspects of challenges

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Asian Journal of Pharmaceutical Sciences 2023年第2期18卷 28-48页

作者： Nazurah Binti Sazali Lai Wah Chan Tin Wui Wong Department of Pharmacy Faculty of ScienceNational University of SingaporeSingapore 117543Republic of Singapore Non-Destructive Biomedical and Pharmaceutical Research Centre Smart Manufacturing Research InstituteUniversiti Teknologi MARA SelangorSelangor 42300Malaysia Particle Design Research Group Faculty of PharmacyUniversiti Teknologi MARA Selangor 42300Malaysia

Nanoscale medicine confers passive and active targeting *** development of nanomedicine is however met with processing,handling and administration *** solid nanoparticle aggregation and caking result in lowproduct yield,poor particle flowability and inefficient drug *** are overcome by converting the nanoparticles into a microscale dosage form via agglomeration or compaction *** and compaction nonetheless predispose the nanoparticles to risks of losing their nanogeometry,surface composition or chemistry being altered and negating biological *** study reviews risk factors faced during agglomeration and compaction that could result in these changes to *** potential risk factors pertain to materials choice in nanoparticle and microscale dosage form development,and their interplay effects with process temperature,physical forces and environmental *** render the physicochemical and biological behaviour of the nanoparticles unaffected by agglomeration or compaction,modes to modulate the interplay effects of material and formulation with processing and environment variables are discussed.

关键词： Agglomeration Compaction excipient Nanomedicine Nanostructure

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Study on the Forming Process of Yi Medicine Tongfeng Granules

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Medicinal Plant 2021年第6期12卷 37-39,43页

作者： Xuelian ZHAO Yisong LI Ling TAN Hongna SU Junzhang QUBIE Wenbing LI Yuan LIU Pharmacy College Southwest Minzu University Chengdu 610041 China Sichuan Provincial Qiang-Yi Medicinal Resources Protection and Utilization Technology Engineering Laboratory Chengdu 610225 China Key Laboratory of Tibetan Plateau Ethnic Medicinal Resources Protection and Utilization of National Ethnic Affairs Commission of the People's Republic of China Chengdu 610225 China Institute of Qinghai-tibetan Plateau Southwest Minzu University Chengdu 610041 China Ethnic Medicine Institute Southwest Minzu University Chengdu 610041 China

[Objectives]To optimize the forming process of Yi medicine Tongfeng Granules.[Methods]The forming process of Yi medicine Tongfeng Granules was optimized,with paste density,ethanol volume fraction,and type and proportion of excipient as influencing factors,and granule formability,solubility,moisture absorption,and angle of repose as evaluation *** relative humidity(CRH)was investigated to select optimal storage conditions.[Results]Maltodextrin was selected as the excipient,and the best process parameters was the ratio of drug to excipient at 1∶2(g/g),under which the forming rate,solubility,moisture absorption rate,and angle of repose were 81.38%,98.90%,8.81%,and 27.5°,*** critical relative humidity was 72%.[Conclusions]The forming process adopted is reasonable and feasible,and can provide a reference for large-scale production of Yi medicine Tongfeng Granules.

关键词： Yi medicine Tongfeng Granules excipient Forming process Critical relative humidity

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Neonates need tailored drug formulations

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World Journal of Clinical Pediatrics 2013年第1期2卷 1-5页

作者： Karel Allegaert Department of Development and Regeneration University Hospitals 3000 LeuvenBelgium Neonatal Intensive Care Unit University Hospitals Leuven 3000 Leuven Belgium

Drugs are very strong tools used to improve outcome in neonates. Despite this fact and in contrast to tailored perfusion equipment, incubators or ventilators for neonates, we still commonly use drug formulations initially developed for adults. We would like to make the point that drug formulations given to neonates need to be tailored for this age group. Besides the obvious need to search for active compounds that take the pathophysiology of the newborn into account, this includes the dosage and formulation. The dosage or concentration should facilitate the administration of low amounts and be flexible since clearance is lower in neonates with additional extensive between-individual variability. Formulations need to be tailored for dosage variability in the low ranges and also to the clinical characteristics of neonates. A specific focus of interest during neonatal drug development therefore is a need to quantify and limit excipient exposure based on the available knowledge of their safety or toxicity. Until such tailored vials and formulations become available, compounding practices for drug formulations in neonates should be evaluated to guarantee the correct dosing, product stability and safety.

关键词： Drug formulation Newborn excipient Safety Quality control

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Advances in Study on Three-dimensional Printing in Pharmaceutics

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Chinese Herbal Medicines 2016年第2期8卷 121-125页

作者： Fang Zheng Sheng-wu Huang Zhejiang Chinese Medical University Hangzhou 310053China

Three dimensional printing（3DP） is a solid freeform fabrication technology which employs powder processing and a liquid binder material in the construction of parts in a layer-wise manner. 3DP can accommodate much geometric outline and be made with many materials due to its unprecedented flexibility. The technology can control over the material composition, microstructure and surface texture so it attracts great attentions in the pharmaceutics field. 3DP can offer many novel strategies and approaches for the research and is widely focused in the field of the controlled-release drug delivery systems. Through consulting a large number of documents the current development and the technical characteristics of 3DP in pharmaceutics field are discussed and reviewed. It is expected that 3DP technique may play a tremendous role in pharmaceutics field in the *** dimensional printing （3DP） is a solid freeform fabrication technology which employs powder processing and a liquid binder material in the construction of parts in a layer-wise manner. 3DP can accommodate much geometric outline and be made with many materials due to its unprecedented flexibility. The technology can control over the material composition, microstructure and surface texture so it attracts great attentions in the pharmaceutics field. 3DP can offer many novel strategies and approaches for the research and is widely focused in the field of the controlled-release drug delivery systems. Through consulting a large number of documents the current development and the technical characteristics of 3DP in pharmaceutics field are discussed and reviewed. It is expected that 3DP technique may play a tremendous role in pharmaceutics field in the future.

关键词： controlled-release drug delivery excipient pharmaceutics three dimensional printing

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