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Common types of direct compression accessories and characteristics
MicrocrystallinecelluloseThisproductiswhiteoroff-whitepowder,odorless,tasteless,insolubleinwater,ethanol,acetoneortoluene,hasverygoodcompressibility,andhascertainfluidityanddisintegration.Itisatablet.Excellentfillerandeffectivedryadhesive,ithasgoodhardnessafterbeingpressedintotablets,anddoesnotaffectdisintegration.Thevarietyhasalargecapacityforthedrug,anditsdosagecanbefrom5%to65%.However,thisvarietyishygroscopic.NowtherearealreadyproductsinChina.Pre-gelatinizedstarchThisproductiswhitepowder,odorless,tasteless,goodfluidity,nationalproductangleofreposeis36.6degrees,goodcompressibility;lubrication,canreducetheforceofthetabletfromthediehole;goodThedisintegrationanddryadhesionincreasethehardnessofthetabletandreducethefriability.Thisproductisanidealmulti-functionalauxiliarymaterialfordirectcompressionofpowder.Thedosageisgenerally5%~20%.Lactosespray-driedlactoseisanauxiliarymaterialusedfordirectcompressionofpowder.Itisawhitecrystallinepowderandhasnohygroscopicity.Thesurfaceofthepressedtabletissmoothandbeautiful,andthedrugisreleasedquickly.Thefluidityandadhesionaregood.Filler.Whentheamountismorethan50%,thehydrophobicityofthedrugcanbeimproved.SodiumcarboxymethylstarchThisproductisanexcellentdisintegratingagentfortablets.Itiswhiteoroff-whitepowder,odorless,hygroscopicinair,dispersedintoaviscouscolloidalsolutioninwater;hasgoodhydrophilicityandwaterabsorption.Swellability;andgoodfluidityandcompressibility,canimprovetheformabilityofthetablet,increasethehardnessofthetabletwithoutaffectingitsdisintegration.Fortabletsofpoorlysolubledrugs,thisproductcanimproveitsdisintegration.Thegeneraldosageis1%to8%.CalciumhydrogenphosphateThisproductisawhitepowder,odorless,tasteless,insolubleinwaterorethanol,hasmoistureresistance;hasgoodfluidityandstability,andisinexpensive;thepressedtablethasgoodhardness.Whenthetabletcontains50%calciumhydrogenphosphate,thedisintegrationisveryrapid.Micro-silicagelThisproductisalightwhiteanhydrouspowder,odorless,odorless,largespecificsurfacearea,isacommonlyusedtabletglidant,hasagreateradhesiontodrugs.Thehydrophilicpropertyisstrong,andwhenthedosageisabove1%,thedisintegrationofthetabletcanbeaccelerated,andthedisintegrationisextremelyfine,therebyimprovingthedissolutionofthedrugandfacilitatingtheabsorptionofthedrug.Thegeneraldosageis0.15%to3%.MagnesiumstearateThisproductisawhite,easyandno-sandfinepowder.Ithasaslipperyfeelwhenincontactwiththeskin.Itisinsolubleinwaterandhasgoodadhesion.Thisproductisacommonlyusedhydrophobiclubricant,whichcaneffectivelysolvethestickingphenomenon,andthesurfaceissmoothandbeautiful.Thegeneraldosageis0.2%to1%.Otherssuchaslow-substitutedhydroxypropylcellulose,starch,talc-magnesiumstearatemixedpowder,aluminum-magnesiumrawpowderandthelike.
2018-12-18
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The development of pharmaceutical excipients is getting healthier
Market size is about 5 billion
China's pharmaceutical excipients industry is highly fragmented. Up to now, there are many statistics on the scale and current status of the domestic pharmaceutical excipient market, but they lack authority. How large is the size of the entire market, and in the absence of relevant statistics, can it give a rough figure through scientific and reasonable analysis and inference? Yu Zhanwen, secretary general of the China Pharmaceutical Industry Research and Development Promotion Association, believes that the variety of pharmaceutical excipients is not as easy to manage as drugs, and the statistics of relevant market data are difficult to be precise, but some industry insiders who understand the development of the industry can follow their own business. Experience and give a rough outline by scientific analysis of relevant data.
“Over the decades of development of excipients, almost no enterprises have specially developed new materials for pharmaceutical excipients.” Wang Ran, general manager of Tianjin Ailei Pharmaceutical Materials Co., Ltd. pointed out that only cydex's beta-cyclodextrin derivative has been produced so far. The materials are specially developed for medicinal use. Most of the varieties are made in other industries (such as fine chemicals, food, cosmetics), and then transferred to pharmaceutical excipients. For example, some large-scale pharmaceutical excipients such as starch, lactose, and cellulose all fall into this category. At present, there are few companies producing starch in China that apply for pharmaceutical production approval for medicinal purposes. Many pharmaceutical excipients only account for a small proportion of producers' production. If the requirements for pharmaceutical excipients are too high, some manufacturers may abandon the production of pharmaceutical excipients and switch to other industries. It is precisely because of this consideration that the state does not currently require GMP certification for pharmaceutical excipients, but only for certification. Therefore, market information on pharmaceutical excipients is difficult to count.
Wang Ran, who has been in the pharmaceutical industry for decades, emphasizes that the prescriptions for preparations are fixed, and the production companies generally have little difference. According to conservative estimates, pharmaceutical excipients account for 5% to 10% of the cost of preparation products. These preparations include chemical preparations, biochemical products and proprietary Chinese medicines. As long as the output values of the above three are known, the pharmaceutical excipients can be roughly deduced. output value. According to data released by the Ministry of Industry and Information Technology, in 2008, the chemical preparation industry realized a total industrial output value of 233.6 billion yuan, the biochemical and biochemical products manufacturing industry completed 76.87 billion yuan, and the proprietary Chinese medicine manufacturing industry reached 177.94 billion yuan. 488.41 billion yuan. According to the average profit rate of about 20% in the pharmaceutical industry, according to conservative calculations, the total output value of domestic pharmaceutical excipients in 2008 was about 5 billion yuan.
Another method is to use bulk products to calculate, because bulk products account for a large proportion of the entire pharmaceutical excipients. For example, lactose, starch, mannitol, cellulose ethers, resins and hollow capsules in solid preparations, glycerides in ointments, PEG, etc., sucrose, sodium chloride, etc. in liquid preparations, etc. About 5 billion yuan.
In addition, it can also be measured by the sales of pharmaceutical excipients. At present, there are about 50 relatively standardized pharmaceutical excipients in China, with annual sales of around 30 million to 80 million yuan and total sales of 2 billion to 4 billion yuan. In addition, there are more than 10 foreign-funded pharmaceutical excipients in China, with a conservative estimate of 40 million yuan in annual sales, and total sales of about 500 million yuan. The sales of these companies add up to about 4.5 billion yuan.
"There is statistics that the total output value of the domestic pharmaceutical excipients industry is about 100 million US dollars. This figure is not credible." Yu Zhanwen believes that according to scientific analysis and inference, the total output value should be 600 million to 700 million US dollars. The growth rate is generally the same as that of the pharmaceutical industry. In 2008, the growth rate of the domestic pharmaceutical industry was about 25%, and the growth rate of the pharmaceutical accessories industry was probably such a trend.
Broad prospects for industrial development
According to relevant data, in 2001, the global market for pharmaceutical excipients totaled about US$3 billion, of which about 70% were in Europe and America, and 15% in Japan, with an
2018-12-18
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Promising prospects for pharmaceutical excipients
The domestic pharmaceutical excipients industry started late, and there are many problems in terms of scale, management regulations, and standards. Recently, China has researched and implemented the DMF (main quality management of pharmaceutical raw materials) system to strengthen raw materials, excipients, chemical intermediates and Management of pharmaceutical packaging materials. The purpose of promoting DMF is to improve the status quo of the auxiliary materials industry, and at the same time drive the preparation manufacturers not only the product quality, but also must go out and learn more about the whole production process and quality of the raw and auxiliary materials packaging materials, so that the quality of the auxiliary materials will be greatly improved. The auxiliary industry is good news. The 21st century international pharmaceutical market will be the day of new pharmaceutical preparations
2018-12-18
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2015' China Pharmaceutical Preparation Technology Application Forum - Chongqing Station
2015’ China Pharmaceutical Preparation Technology Application Forum
In order to promote the exchanges between pharmaceutical companies and pharmaceutical excipients and pharmaceutical equipment companies; in order to encourage preparation companies to make full use of new excipients, new equipment and innovative technology, improve the quality of original products and production efficiency, especially for generics The evaluation was carried out for secondary development to bring it into line with the original research. The 2015’ Pharmaceutical Preparation Technology Application Forum is scheduled to be held in Chongqing from April 21st to 22nd, 2015.
The seminar will invite technical leaders from domestic and foreign accessories and equipment companies to give a keynote report, focusing on the application of new excipients and case sharing and direct tableting technology demonstration. It is hoped that relevant personnel involved in formulation research and development, technology, production, quality and procurement will participate in this forum. The meeting arrangement and location are as follows. Organizer: National Pharmaceutical Technology Market Association
Venue: Chongqing Changdu Holiday Hotel Address: No. 96, Wuhong Road, Yubei District, Chongqing (Red Metro Station, Metro Line 6) Meeting time: April 21-22, 2015 (two days)
Conference fee: free
April 22, 13:40-14:20
Xu Shizhen, Sales Director of Shanghai Shenmei Pharmaceutical Development Technology Co., Ltd. will introduce
"Case analysis of microcrystalline cellulose and croscarmellose sodium in oral solid preparations" Welcome to listen! !
2018-12-18
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