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Technology Transfer Agency in India 印度技术转移机构
Pub Date : 2023-03-22 DOI: 10.52711/2231-5713.2023.00011
Y. Chowdhary, Babita Kumar
Transfer of technology is defined as “a logical procedure that controls the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacture sites” • Technology transfer is both integral and critical to the drug discovery and development .Technology of transfer may be defined as a mutually agreed upon, intentional, goal-oriented, and proactive process by which technology flows from an entity that owns the technology (the transferor) to an entity seeking the technology (the transferee). Government of India is in the verge to open Technology Transfer Offices, Universities, institutions which will be funded by central government and will acts as mechanism for transferring or exporting the research conducted and its outcome to the desired place. Examples of technology transfer can be found across virtually every scientific and industrial area, from pharmaceuticals and medical devices to alternative energy solutions, computing, transport, artificial intelligence, robotics, agriculture, aerospace, environmental improvements and many more.. To overcome these limitations, the four levels of knowledge and technology transfer are suggested: Technology transfer can be broadly classified into vertical and horizontal technology transfer. Vertical Technology Transfer– This chain of transfer includes basic research to applied research, applied research to development, and from development to production. It is also known as internal technology transfer. Technology transfer is a process to transfer information and technologies necessary to manufacture quality drug product consistently or technology transfer is the process of taking an invention from its inception in a laboratory to a commercialized product.
技术转让被定义为“在开发和生产之间或生产地点之间控制任何过程及其文件和专业知识转让的逻辑程序”•技术转让对药物发现和开发来说既是不可或缺的,也是至关重要的。技术转让可以定义为双方同意的,有意的,目标导向的,技术从拥有技术的实体(转让方)流向寻求技术的实体(受让方)的主动过程。印度政府即将开设技术转移办公室、大学和机构,这些机构将由中央政府资助,并将作为转移或出口所进行的研究及其成果的机制。几乎在每个科学和工业领域都可以找到技术转让的例子,从制药和医疗设备到替代能源解决方案、计算、运输、人工智能、机器人、农业、航空航天、环境改善等等。为克服这些局限性,本文提出了知识和技术转移的四个层次:技术转移可大致分为纵向技术转移和横向技术转移;垂直技术转移——这条转移链包括基础研究到应用研究,应用研究到开发,以及从开发到生产。它也被称为内部技术转让。技术转让是指为持续生产高质量药品而转让信息和技术的过程,或者技术转让是指将一项发明从实验室开始变成商业化产品的过程。
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引用次数: 0
Development of Fast Dissolving Tablets of Losartan Potassium using Novel Co-processed Superdisintegrants 新型协同加工超崩解剂制备氯沙坦钾速溶片
Pub Date : 2023-03-22 DOI: 10.52711/2231-5713.2023.00003
B. Hemalatha, P. Bhuvaneswari, G. Kalyani, N. K. Veni, K. Naga Durga, P. Yashwanthi, K. Padmalatha
Losartan is used to treat high blood pressure (hypertension) and also used to lower the risk of stroke in certain people with heart disease. Therefore, the purpose of this study is to formulate mouth dissolving tablet of losartan potassium to improve its bioavailability, to attain fast onset of action and rise patient compliance. Owing to short bioavailability of 33% and to increase onset of action, fast dissolving tablets of Losartan Potassium were formulated using coprocessed superdisintegrants in order to improve the dissolution rate, in that way the bioavailability. The effect of concentration of the Croscarmellose sodium was studied by a set of three formulations (F1, F2, F3) with concentrations of 2%, 4% and 8% w/w respectively. Similarly, the impact of Sodium Starch Glycolate was studied by a set of three formulations (F4, F5 and F6) respectively. The formulation prepared with 8% w/w of superdisintegrant showed relatively rapid release of Losartan potassium when compared with other concentrations of Croscarmellose sodium and Sodium Starch Glycolate. The formulation prepared with Croscarmellose sodium had showed relatively fast release of Losartan Potassium when compared with Sodium Starch Glycolate. Three formulations (F7, F8 and F9) were prepared by including a combination of superdisintegrants (Co-processed Mixtures), Croscarmellose sodium and Sodium Starch Glycolate by direct compression method. Formulation containing Co-processed mixtures had less disintegration time as compared to the individual superdisintegrants. Subsequently, we can conclude that nature, concentration of the superdisintegrant in addition to combination of superdisintegrants (Co-processed) showed influence on the rate of dissolution.
氯沙坦用于治疗高血压,也用于降低某些心脏病患者中风的风险。因此,本研究的目的是研制氯沙坦钾口服溶片,以提高其生物利用度,达到快速起效,提高患者依从性。由于氯沙坦钾的生物利用度较短,只有33%,为提高起效性,采用超崩解剂配制氯沙坦钾速溶片,以提高溶出速度,从而提高生物利用度。采用F1、F2、F3三种配方(分别为2%、4%和8% w/w),研究了交联棉糖钠浓度的影响。同样,研究了乙醇酸淀粉钠分别用3种配方(F4、F5和F6)对其影响。当超崩解剂质量分数为8%时,氯沙坦钾的释放速度明显快于其他浓度的交联棉糖钠和淀粉乙醇酸钠。与乙醇酸淀粉钠相比,以交联棉糖钠制备的氯沙坦钾释放速度相对较快。以超崩解剂(共加工混合物)、交联棉糖钠和淀粉乙醇酸钠为原料,采用直接压缩法制备了F7、F8和F9三种配方。与单个超崩解剂相比,含有共处理混合物的配方崩解时间更短。随后,我们可以得出结论,超崩解剂的性质、浓度以及超崩解剂的组合(共处理)对溶解速度有影响。
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引用次数: 0
A Review on Osmotic Drug Delivery System 渗透给药系统研究进展
Pub Date : 2023-03-22 DOI: 10.52711/2231-5713.2023.00014
G. S. Vani, C. Kiranmai, B. H. Latha, K. Padmalatha
Conventional drug delivery systems have slight control over their drug release and nearly uncontrollable over the effective concentration at the target site. This type of dosing pattern might effect on constantly changing, unpredictable plasma concentrations. Drugs can be delivered in a controlled design over a prolonged period of time by the controlled or modified release drug delivery systems. For most of the drugs, oral route is the most tolerable route of administration. Certain molecules may have low oral bioavailability because of solubility or permeability limitations. Evolution of an extended-release dosage form also need sensible absorption throughout the gastro-intestinal tract (GIT). Among the existing techniques to improve the bioavailability of these drugs fabrication of osmotic drug delivery system is the most suitable one. Osmotic drug delivery systems release the drug with the zero-order kinetics at a constant rate. This review brings out advantages, disadvantages, principles, basic components and classification of osmotic drug delivery systems.
传统的药物传递系统对其药物释放有轻微的控制,对靶点的有效浓度几乎不可控。这种给药模式可能对不断变化的、不可预测的血浆浓度产生影响。药物可以通过控制或修改的释放给药系统在一段较长的时间内以受控设计递送。对于大多数药物,口服是最耐受的给药途径。由于溶解度或渗透性的限制,某些分子可能具有低的口服生物利用度。缓释剂型的演变也需要整个胃肠道(GIT)的敏感吸收。在现有的提高这些药物生物利用度的技术中,制造渗透给药系统是最合适的一种。渗透给药系统以恒定速率以零级动力学释放药物。本文综述了渗透给药系统的优点、缺点、原理、基本组成和分类。
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引用次数: 0
Novel Formulation for Treatment of Mouth Ulcer 治疗口腔溃疡的新配方
Pub Date : 2023-03-22 DOI: 10.52711/2231-5713.2023.00004
Rina G. Maskare, Shital D. Thakre, Om D. Patle, Shirali S. Vishwakarma, Dhyanesh N. Dahake, Rima J. Jagnit, Rohit S. Rahangdale
Mouth ulcer also known as cankers ulcer are normally small painful abscess that can develop in your mouth or the base of your gum due to these we feel uncomfortable in eating, drinking and talking. Women’s, adolescent and people with a family history of mouth ulcers are higher risk for developing mouth ulcer. There is no major drug therapy required for treatment of mouth ulcer, usually people prefer home remedies. But it is not convenient to take , dose variation may occur because there is no definite quantity given, and also it is unpleasant sometimes irritable thus accordingly we formulate candy like formulation that is lozenges which composed of herbal ingredient like, guava leaves , pigeon pea leave, Tulsi, mint, turmeric, liquorice, clove binded with dextrose , which is convenient for patient The prepared lozengesare evaluated for stability parameter, according to ICH Guideline, the improved formulative lozenges where evaluated for physical characters and results comes under pharmacopeial limit. In-vitro dissolution study show’s 90 % drug release within 30 minutes, the stability studies shows that formulation is stable for last 3 months. Here antimicrobial activity of lozenges is also studied and it shows the positive result for topical application.From recent work it was assured that the herbal lozenges can be considered as a reliable delivery system for the treatment of mouth ulcer.
口腔溃疡也被称为口腔溃疡,通常是一种小而疼痛的脓肿,可以在你的口腔或牙龈底部发展,因为这些我们在吃、喝和说话时感到不舒服。女性、青少年和有口腔溃疡家族史的人患口腔溃疡的风险更高。治疗口腔溃疡不需要主要的药物治疗,通常人们更喜欢家庭疗法。但由于服用不方便,由于没有明确的剂量,可能会发生剂量变化,而且有时会令人不愉快,因此我们配制了类似糖果的配方,即由番石榴叶、鸽豆叶、土尔丝、薄荷、姜黄、甘草、丁香等草药成分与葡萄糖结合而成的含片,以方便患者。改进的配方含片的物理特性和结果在药典的限制下进行了评估。体外溶出度研究表明30分钟内90%的药物释放,稳定性研究表明制剂稳定3个月。本文还对含片的抗菌活性进行了研究,结果表明局部应用效果良好。从最近的工作中可以肯定,草药含片可以被认为是治疗口腔溃疡的可靠的输送系统。
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引用次数: 0
Vaccine through Centuries. Major Cornerstone of Global Health 几百年来的疫苗。全球卫生的主要基石
Pub Date : 2023-03-22 DOI: 10.52711/2231-5713.2023.00013
R. Haider
Vaccine have a history that started late in the 18th century. From the late 19th century, Vaccine could be developed in the laboratory, However, In the 20th century it became possible to develop vaccine based on Immunologic makers In the 21st century molecular biology permits vaccine development that was not possible before. In the history of science is the impact of vaccines on human longevity and health over 300 years elapsed since the first vaccine was discovered. In short article it is not possible to do justice to a subject that encompases immunology, molecular biology, and public health, but several more extensive sources are available to the interested reader 1-5 rather than attempting a chronological narrative, In current articles that describe novel technologies, it is often said that they will enable " rational" development of vaccines. The opposite of rational is irrational, but presumably the writer mean to contrast rational with "empiric" However, in fact vaccine development has been based on rational choices ever since the mid 20th century, when the immunology advanced to the point of distinguishing protection mediated by antibody and that mediated by lymphocytes, and when passage in cell culture permitted the selection of attenuated mutants, After the point successful vaccine have been " rationally" developed by protection studies in animal, by inference from immune response shown to protect against repeated natural infection (the so called mechanistic correlates of protection) 6 and from the use of passive administration of antibodies against specific antigens to show that those antigens should be included in vaccines.
疫苗的历史始于18世纪末。从19世纪末开始,疫苗可以在实验室中开发,然而,在20世纪,基于免疫制造商开发疫苗成为可能。在21世纪,分子生物学使疫苗开发成为可能,这在以前是不可能的。在科学史上,自从第一种疫苗被发现以来,疫苗对人类寿命和健康的影响已经过去了300多年。在一篇简短的文章中,不可能公正地对待一个包含免疫学、分子生物学和公共卫生的主题,但对于感兴趣的读者来说,有几个更广泛的来源,而不是试图按时间顺序叙述。在当前描述新技术的文章中,经常说它们将使疫苗的“合理”发展成为可能。理性的对立面是非理性,但作者大概是想将理性与“经验”进行对比。然而,事实上,自20世纪中期以来,当免疫学发展到区分抗体介导的保护和淋巴细胞介导的保护的程度时,当细胞培养中的传代允许选择减毒突变体时,疫苗的开发一直基于理性选择。通过在动物身上进行的保护性研究,从免疫反应中得出的结论(所谓的保护性机制相关关系),以及从被动使用针对特定抗原的抗体中得出的结论(表明这些抗原应包括在疫苗中),"合理地"研制出成功的疫苗。
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引用次数: 0
Formulation and Evaluation of Floating Tablet of Nabumetone 纳布美酮漂浮片的处方及评价
Pub Date : 2023-03-22 DOI: 10.52711/2231-5713.2023.00006
Parmeet K Saluja, N. Jain, N. Jain
Nabumetone was used as a model drug in this study to construct and assess floating tablets. By adjusting the drug to polymer ratio to 1:1, 1:1.5, and 1:2, naproxen sodium floating tablets were made utilising the wet granulation method. As generating agents, sodium bicarbonate and citric acid are utilised. With isopropyl alcohol acting as the solvent, lactose is employed as diluents and PVP K30 as a granulating agent. The formulation of the granules was assessed for flow properties, and the tablets were made and assessed for physical characteristics, invitro buoyancy testing, and drug content. All of the formulations displayed values that were within the permitted range, demonstrating the high calibre of the manufactured tablets. A decrease in the density of the tablet below 1 and the emergence of buoyancy were noticed as a result of the gas created being confined and protected within the gel formed by the polymers. As the polymer to drug ratio increases, it was seen that the floating lag time in the formulations F1 to F6 decreased while the total floating duration increased. Drug release from the formulations made in a 1:1 ratio occurred at a higher rate and to a greater extent (i.e. F1, F4, and F7). The produced tablets underwent evaluations for uniformity, hardness, friability, drug content, in vitro buoyancy experiments, and dissolving investigations. In addition, the invitro release data were fitted to various kinetic models.
本研究以纳布美酮为模型药物,构建并评价其漂浮片剂。将药药比调整为1:1、1:1.5、1:2,采用湿法制备萘普生钠浮片。用碳酸氢钠和柠檬酸作为生成剂。以异丙醇为溶剂,乳糖为稀释剂,PVP K30为造粒剂。对颗粒剂的配方进行了流动性能评估,对片剂进行了物理特性评估、体外浮力测试和药物含量评估。所有配方显示的数值都在允许范围内,表明生产的片剂质量高。由于产生的气体被限制和保护在聚合物形成的凝胶中,因此注意到药片的密度降低到1以下并出现浮力。随着药药比的增加,F1 ~ F6配方的漂浮滞后时间减小,总漂浮时间增加。以1:1比例配制的制剂的药物释放速率更高,程度更大(即F1, F4和F7)。对所制片剂进行均匀性、硬度、脆性、药物含量、体外浮力实验和溶出度评价。此外,体外释放数据拟合了各种动力学模型。
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引用次数: 0
IVF Modules of Management for Nurses and Clinical Practitioners which will help to add and keep track of Fertility Treatments 为护士和临床医生提供试管婴儿管理模块,这将有助于增加和跟踪生育治疗
Pub Date : 2023-03-22 DOI: 10.52711/2231-5713.2023.00009
Wajid Ahmad, Jaza Quazi
Infertility is a common problem that requires timely and sensitive intervention. The use of In-Vitro Fertilization (IVF) is now becoming a popular experience in developing countries. Infertility can be managed primarily by improving lifestyle, diet, exercise, and Couples should be advised of the importance of regular sexual intercourse every 2 or 3 days, regardless of the woman’s cycle. A drug like clomifene use in the primary treatment of infertility. Before and during the IVF nursing staff plays an important role in executes treatment plans that fertility doctors formulate with couples starting at the initial visit and also plays important role in supporting patients Psychologically. Some complications like multiple births, sex ratio distortions, and the spread of infectious diseases.
不孕症是一个常见的问题,需要及时和敏感的干预。使用体外受精(IVF)现在正在发展中国家成为一种流行的经验。不孕症主要可以通过改善生活方式、饮食、锻炼来控制。无论女性的月经周期如何,应告知夫妇每2或3天定期性交的重要性。一种药物,如克罗米芬,主要用于治疗不孕症。在试管婴儿之前和期间,护理人员在执行生育医生与夫妇从初次就诊开始制定的治疗计划方面发挥着重要作用,并且在心理上支持患者方面也发挥着重要作用。一些并发症,如多胞胎、性别比例扭曲和传染病的传播。
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引用次数: 0
Formulation and Evaluation of Nanosuspension of Ambroxol Hyrochloride 盐酸氨溴索纳米混悬液的制备及性能评价
Pub Date : 2023-03-22 DOI: 10.52711/2231-5713.2023.00002
M. Andhale, U. T. Jadhao, D. Rathod, S. Thoke, G. N. Dhembre
The aim of the present investigation was to Formulation and evaluation of Nanosuspension of Ambroxol hydrochloride for pediatric use. Ambroxol hydrochloride is a mucolytic agent used to treat respiratory diseases associated with viscid or excessive mucus accumulated in respiratory tract. The present research involved to find out the effect of different polymer and their ratio on the formulation of ambroxol hydrochloride oral nanosuspension. The prepared nanosuspension is evaluated by solubility, particle size, entrapment efficiency, DSC study, SEM analysis, re-dispersion study, sterility and In-vitro drug release studies shows that the prepared nanosuspension has increased solubility and dissolution rate compared to pure drug. The formulated F5 has shown the better results like as UV rage is 244nm, soluble in methanol, particle size and Stability.
本研究旨在探讨盐酸氨溴索小儿用纳米混悬液的配方及评价。盐酸氨溴索是一种解黏液剂,用于治疗呼吸道黏液积聚过多引起的呼吸道疾病。研究了不同聚合物及其配比对盐酸氨溴索口服纳米混悬液配方的影响。对制备的纳米混悬液的溶解度、粒径、包封效率、DSC研究、SEM分析、再分散研究、无菌性和体外药物释放研究进行了评价,结果表明制备的纳米混悬液的溶解度和溶出率均高于纯药物。配制的F5在紫外范围为244nm、可溶于甲醇、粒径大小、稳定性等方面均取得了较好的效果。
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引用次数: 0
Formulation and Evaluation of Sotalol Gastrorententive Tablets 索他洛尔胃膨松片的处方及评价
Pub Date : 2023-03-22 DOI: 10.52711/2231-5713.2023.00008
G. Swathi, Krishna Jyothi Kumari Bhavan, R. Sri. S
The objective of this study was to formulate floating tablets (GRDDS) of Sotalol using direct compression method to increase its bioavailability and the gastric residence time of the dosage form. The Sotalol tablets were prepared by direct compression method. The tablets were prepared by using different types of polymers i.e.; Sodium CMC, Chitosan and Psyllium Husk which act as a release retardant polymer. Sodium bi carbonate (NaHCO3) was used as a gas degenerating agent and MCC (Micro crystalline cellulose) was used as a diluent. The prepared formulation were subjected to some evaluation parameters like hardness, friability, weight variation, drug content, buoyancy property, drug release study etc. In the FT-IR study it was revealed that there is no interaction between the drug and excipients. The formulation which containing Chitosan polymer and Sodium bicarbonate shows good drug release pattern with less floating lag time and good floating duration.The in vitro drug release pattern of Sotalol floating tablets was fitted to different kinetic models which showed the highest regression for Higuchi order kinetics. Thus, it can be concluded that the floating drug delivery system of Sotalol using the appropriate polymers in right amount may enhance the activity of the drug by prolonging the gastric residence time or reducing the floating lag time.
本研究的目的是采用直接压缩法制备索他洛尔浮片,以提高其生物利用度和胃停留时间。采用直接压缩法制备索他洛尔片。片剂由不同类型的聚合物制备,即;CMC钠、壳聚糖和车前草壳作为缓释聚合物。以碳酸氢钠(NaHCO3)为气体降解剂,微晶纤维素(MCC)为稀释剂。对制备的制剂进行了硬度、脆性、重量变化、药物含量、浮力、释放度等评价指标的研究。在傅里叶变换红外光谱研究显示,没有相互作用之间的药物和辅料。由壳聚糖聚合物和碳酸氢钠组成的配方具有良好的药物释放模式,漂浮滞后时间短,漂浮持续时间长。索他洛尔浮片的体外释放模式符合不同的动力学模型,其中对通口级动力学的回归程度最高。由此可见,在索他洛尔漂浮给药系统中加入适量合适的聚合物,可以通过延长胃停留时间或减少漂浮滞后时间来提高药物的活性。
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引用次数: 0
Articulation and Evaluation of Extended-Release Beads using a Sulfasalazine Drug 柳氮磺胺嘧啶类药物缓释微珠的制备与评价
Pub Date : 2023-03-22 DOI: 10.52711/2231-5713.2023.00005
K. Krishna, V. Patro
The present study was focused on optimization of the formulation for the extended-release capsule of mesalamine. Multi particulate system has long been employed to improve the bioavailability of drugs. Mesalamine pellets were prepared by Coating drug solution on sugar sphere followed by functional coating. The release pattern depends upon the pore formation on the outer surface of the unit particle or beads and then slowly and steadily releasing drugs from the inner core. Ethocel grade 7cps was used as a release controlling polymer with the aid of hydrophilic polymer HPMC E5 with pore former to work as a controlled drug delivery system. The functional coated Pellets were used for various parameters like assay and in-vitro dissolution profile. The study confirmed that mesalamine can deliver its effect into lower part of intestine. The finally prepared pellets were used for the treatment of IBD (Ulcerative colitis) Batch 2 had gave optimised result which follow the US specification. Kinetics was applied to the optimized Batch B-2 which was following Higuchi matrix and the mechanism of release was diffusion as the polymer used was HPMC E5 and Tri ethyl citrate –pore former and Ethocel- impenetrable barrier.
本研究主要对美沙拉明缓释胶囊的处方进行优化。多颗粒系统长期以来被用于提高药物的生物利用度。采用糖球包覆药液,再包覆功能包覆法制备美沙拉胺微丸。释放模式取决于单位颗粒或小珠的外表面孔隙的形成,然后缓慢而稳定地从内核释放药物。以乙塞酯级7cps为控释聚合物,与具有孔前形成的亲水性聚合物HPMC E5共同作为控释给药体系。对功能包被微丸进行了测定和体外溶出度等参数分析。研究证实,美沙拉胺可以将其作用传递到肠道下部。最后制备的微丸用于治疗IBD(溃疡性结肠炎),第2批给出了符合美国规范的优化结果。优化后的B-2批为Higuchi基质,采用HPMC - E5和柠檬酸三乙酯-孔洞形成剂和乙塞酯-不可穿透屏障,以扩散为释放机制。
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引用次数: 0
期刊
Asian Journal of Pharmacy and Technology
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