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Excipient - Wikipedia, the free encyclopedia An excipient is an inactive substance used as a vehicle for medication, or an active ingredient. Depending on the route of administration, and medication form, various excipients may be used. The formulation of these excipients in many cases is considered a trade secret. en.wikipedia.org /wiki/Excipient   (547 words)

[No title]   (Site not responding. Last check: 2007-09-10) Excipient as claimed in claim 1 or 2, wherein the concentration of primary carrier material at stage 2 of the twin stage impinger determined by the antrone reaction is at least 20%. Excipient as claimed in claims 4-7, wherein the drying is performed while the granules are kept in motion, such as in a fluid bed dryer. Excipient as claimed in claims 20-23, wherein the drying is performed while the granules are kept in motion, such as in a fluid bed dryer. www.wipo.int /cgi-pct/guest/getbykey5?KEY=03/86358.031023&ELEMENT_SET=DECL   (2213 words)

Patent RE38,912 The excipient which may be used in the process according to the invention preferably has an average particle size of 10 to 100 μm, preferably 15 to 80 μm, most preferably 17 to 50 μm. In some cases the excipient may also consist of a mixture of coarser excipient with an average particle size of 15 to 80 μm and finer excipient with an average particle size of 1 to 9 μm, wherein the proportion of finer excipient in the total quantity of excipient may be 1 to 20%. In the case of an excipient mixture of coarser and finer excipient fractions, the preferred processes according to the invention are those that produce inhalable powders in which the proportion of finer excipient constitutes 3 to 15%, most preferably 5 to 10% of the total amount of excipient. www.pharmcast.com /Patents100/Yr2005/Dec2005/120605/RE38912_Powder120605.htm   (3507 words)

Guidance for Industry: Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients It is also intended to foster and expedite the development of new excipients, communicate to pharmaceutical and excipient manufacturers current CDER and CBER recommendations on the nonclinical safety data that should be generated to support excipient development, and increase uniformity within CDER and CBER as to expectations for the nonclinical safety evaluation of excipients. It may be most cost-effective to evaluate excipients for carcinogenicity through inclusion in bioassays that are conducted in support of therapeutic ingredients. For cases in which a new excipient is being developed in relation to a specific product, sponsors are encouraged to consult with the appropriate review division to determine if additional guidance is available. www.fda.gov /cber/gdlns/dvpexcp.htm   (2988 words)

Why Audit a Pharmaceutical Excipient? For the purpose of answering this question, excipient manufacturers are divided into two groups: those that manufacturer almost exclusively for the pharmaceutical industry and those pharmaceutical excipient producers whose major customers are outside the pharmaceutical industry. In addition, organizations new to the pharmaceutical excipients marketplace may find it beneficial to tell customers that while the organization may be new to the pharmaceutical excipient market, they have been audited by an independent auditor and meet the U.S.P. Good Manufacturing Practices for Bulk Pharmaceutical Excipients. Excipient manufacturers may benefit from IPEA's sale of reports to third parties through the Audit Report Program, thereby reducing the number of audits they may experience along with the potential disruption in their production owing to these audits. www.ipeainc.com /why.htm   (711 words)

Excipient Selection Can Significantly Affect Solid-State Phase Transformation in Formulation During Wet Granulation Although excipients are considered to be inert in therapeutic or biological actions, they should hinder unwanted phase transitions and ensure the required stability of the drug in the formulation during the manufacturing process and storage. The effect of an excipient depends on the amount present and, hence, the amount of moisture it brings into the drug-excipient interaction, as well as the relative ability of each solid to take up and retain water at a particular temperature and relative humidity. Excipients are, therefore, important components of pharmaceutical formulations, and they can participate actively in improving the characteristics of formulations. www.aapspharmscitech.org /view.asp?art=pt060241   (6525 words)

Suppository - Wikipedia, the free encyclopedia Except for glycerin suppositories, suppositories are made of a greasy excipient (formerly, cocoa butter) in which the active substance is diluted. This may be a source of discomfort for the patient, as the melted excipient may pass the anus during flatulences. Suppositories are used especially for small child patients, for they may be easier to administer than tablets or syrups. en.wikipedia.org /wiki/Suppository   (193 words)

Patent 5,985,326 It is generally advantageous in step (a) to first co-mix the carrier or excipient together with the solvent or solvents and optional water, thereby providing an initial intimate mixture, prior to addition of the poorly water soluble drug thereto. The carrier or excipient for the drug, and the co-precipitation medium, are respectively chosen so that the carrier or excipient is substantially insoluble in the co-precipitation medium. Particularly preferred is hydroxypropyl methyl cellulose phthalate as a carrier or excipient, and there is further provided by the present invention co-precipitates consisting of Compound A and hydroxypropyl methyl cellulose phthalate, and Compound B and hydroxypropyl methyl cellulose phthalate. www.pharmcast.com /Patents/111699OG/5985326_dispersion111699.htm   (2056 words)

Weapons of Tumor Mass Destruction Excipient manufacturers range from the chemical giants such as Dow Chemical Co. and Union Carbide Corp. to niche producers such as CHR Hansen and Shire Laboratories, Inc. The excipient market yearly ranges between $1 and 2 billion. Although excipients must conform with USP standards in the United States, and in the European Union by European Pharmacopeia (PhEur) monographs when available independently of USP guidance, the IPEC has developed programs and guidelines for the makers, distributors, and users of excipients internationally to help ensure appropriate quality control for their use in pharmaceutical manufacture. Because excipients are part and parcel of drugs consumed, any new excipient compound would have to be assessed in almost the same extensive, and expensive, manner as a new pharmaceutical. pubs.acs.org /subscribe/journals/tcaw/10/i01/html/01lesney.html   (2051 words)

[No title]   (Site not responding. Last check: 2007-09-10) The excipient or excipients may be commercially available in the desired particle size range or may be separated by air classification, sieving or any other method of size classification known in the art. The excipient mixtures may, for example, contain one chemical substance as the fine excipient and a different substance as the coarser excipient. The proportion of excipient material to be used in the inhalable compositions of this invention may vary depending upon the proportion of each active agent, the powder inhaler for administration etc. The proportion may, for example, be about 75% to 99.5% by weight of the composition as a whole. www.wipo.int /cgi-pct/guest/getbykey5?KEY=03/88944.031030&ELEMENT_SET=DECL   (3907 words)

Frequently Asked Questions Pharmaceutical excipients are substances other than the pharmacologically active drug or prodrug which are included in the manufacturing process or are contained in a finished pharmaceutical product dosage form. Users of the excipient are required to submit a DMF reference letter from the excipient manufacturer to the FDA as part of their NDA to allow FDA authority to access the DMF for their application. However, if the excipient has previously been used in an approved Japanese drug application and no standard exists in JP or JPE, then USP/NF grade material may be acceptable until such time as a monograph is developed in JP or JPE. www.ipecamericas.org /public/faqs.html   (1583 words)

Excipient-Excipient Interactions in Pharmaceutical Systems Intended for Topical Application - This article looks at ... Pharmaceutical dosage forms contain both pharmacologically-active compounds and excipients, which have been added to aid the formulation and manufacture of the dosage form. The properties of the final dosage form are highly dependent on the excipients chosen, their concentration and interaction with both the active compound and each other. Excipients cannot be regarded as inert or inactive ingredients and a detailed understanding of their physiochemical properties, safety and handling, and regulatory status is essential for pharmaceutical scientists. www.ptemag.com /pharmtecheurope/article/articleDetail.jsp?id=162596   (596 words)

Don't Miss... ExcipientFest 2006!!! Excipient technology is increasingly complex and strives to create new and improved Excipients that aid in drug delivery and modify drug dissolution. Excipients must be chosen such that the formulation can be processed at conditions where the components are not degraded. Further, Excipient choice is expected to have a direct impact on the dissolution profile and API morphology obtained. www.excipientfest.com /presentations.html   (4964 words)

Adding that "spoonful of sugar"--and more Excipients package active ingredients into discrete amounts that are easy to handle, give medications a specific look and color for branding purposes, or imbue unpleasant-tasting medication with an agreeable flavor to help with patient compliance, among hundreds of other uses. Excipients listed for each category range from compounds as well known as water and alcohol, both used as solvents, to those as curious as microcrystalline cellulose (otherwise known as ground-up wood pulp), a bulking agent. However, for a new excipient to be approved for pharmaceutical use, it must already be in the NF, or risk being rejected by the FDA—a rather chicken-and-egg ordeal. pubs.acs.org /subscribe/journals/mdd/v05/i05/html/05brown.html   (1817 words)

Pharmaceutical Formulation & Quality - Current Issue - In The Lab From Commodities to Specialized Excipients: Considered a traditional excipient and trusted through many years of use, starch is also the source of a variety of complex excipient derivatives. However, none of these two excipients possess the necessary combined properties to meet the requirements of fast tablet compression lines, where problems of poor flow and segregation are critical. Although considered as a traditional excipient and trusted through many years of use, it has also been the source of a variety of complex excipient derivatives in the past. www.pharmaquality.com /mag/112005/pfq_112005_LA3.html   (1649 words)

Drug Delivery Technology - Article Index However, unlike cellulose, the use of chitosan as an excipient in pharmaceutical formulations is a relatively new development. The excipient can serve a number of purposes, including as a coating agent, gel former, controlled-release matrix, in addition to inducing desirable properties, such as mucoadhesion and permeation enhancement to improve oral bioavailability of a drug. Additional safety and toxicology studies in accordance with the FDA’s guidelines for new excipient development would however be desired to further promote the use of this polymer as a pharmaceutical excipient. www.drugdeliverytech.com /cgi-bin/articles.cgi?idArticle=131   (1571 words)

Improvement of Cystic Fibrosis Airway Mucus Transportability by Recombinant Human DNase Is Related to Changes in ... After incubation with rhDNase or excipient each aliquot was centrifuged at 20,000 g for 20 min at 10° C. After centrifugation, the gel and sol phases of the samples were collected separately. The effect of rhDNase on the lipid content of gel and sol phases of mucus is reported in Table 1. The mean viscosity of the mucus gel phase after incubation with the control excipient was 708.9 ± 1,646 Pa · s. ajrccm.atsjournals.org /cgi/content/full/157/6/1779   (3866 words)

PQRI: The Product Quality Research Institute The Excipient Control Working Group of PQRI * is seeking information from Excipient Manufacturers, Excipient Distributors, and Pharmaceutical Companies regarding their practices to reduce redundant testing of excipient attributes for complying with the requirements of multiple pharmacopoeias (namely, USP-NF, Ph.Eur., and JP). This information will be used to help establish recommendations for global harmonization of excipient specifications and to determine the appropriate control procedures needed for demonstration of global compendial compliance. It is important to receive data from as many excipient manufacturers, excipient distributors and excipient users as possible to enhance the relevance of survey findings. www.pqri.org /survey/excipientssurvey.htm   (477 words)

Formulation Design of Double-layer in the Outer Shell of Dry-coated Tablet to Modulate Lag Time and Time-controlled ... Once different excipients were respectively incorporated into the upper layer of the outer shell, different release mechanisms were observed as follows: time-controlled explosion for Explotab, disruption for Avicel and spray-dried lactose, erosion for dibasic calcium phosphate anhydrate, and sigmoidal profile for hydroxypropyl methylcellulose. The lag time and time-controlled dissolution were effectively controlled by the amounts and types of materials (excipients, EC) incorporated into the inner core and/or outer shell, and different compression forces of both layers of the dry-coated tablet. Moreover, the influence of formulations containing different excipients in the upper layer of the outer shell on the lag time and release mechanism of sodium diclofenac from dry-coated tablets was also explored. www.aapspharmsci.org /view.asp?art=aapsj060317   (3308 words)

GTC BIOTHERAPEUTICS ENTERS JOINT VENTURE TO EXPAND rhSA COMMERCIAL OPPORTUNITIES Human serum albumin produced from blood plasma has been used as an excipient to maintain structural stability and activity in many biological drug formulations for long periods of time under a wide range of storage conditions. GTC estimates the total production volume to meet the needs of the excipient market is in the range of one to two metric tons per year. The joint venture structure allows the development of the excipient market by GTC and has the potential to attract additional marketing or strategic partners to this program. www.transgenics.com /pressreleases/pr123002.html   (651 words)

CRODA FOCUS ON EXCIPIENTS   (Site not responding. Last check: 2007-09-10) This excipient can withstand severe processing temperatures as high as 160°C, and remains stable in a pH range of 2 to 10. The excipient is described in monographs of the European Pharmacopoeia and of the Japanese Pharmacopoeia. The advantages to developing formulations based on erythritol are clear: Erythritol is a safe excipient that combines the low hygroscopicity of a polyol-like mannitol with better digestibility than lactose and contains nearly zero calories, making this excipient a great candidate for modern drug formulations. www.pharmaquality.com /aprmay3.html   (721 words)

United States Court of Appeals for the Federal Circuit We affirm the judgment of non-infringement and reverse the judgments of invalidity and unenforceability. Upjohn challenges the jury verdict of non-infringement, stating that it presented undisputed evidence that MOVA’s excipient containing 49% spray-dried lactose and 46-49% Starch 1500 is substantially the same as an excipient containing 70% spray-dried lactose. MOVA argued that the '163 patent states that use of spray-dried lactose as the "preponderant" component is "critical to the success of the present composition." MOVA states that there was substantial evidence upon which the jury could have concluded that the range of permissible equivalents was limited, and did not include MOVA's formulation. www.ll.georgetown.edu /federal/judicial/fed/opinions/99opinions/99-1092.html   (3794 words)

GTC BIOTHERAPEUTICS ENTERS JOINT VENTURE TO EXPAND rhSA COMMERCIAL OPPORTUNITIES - excipient, pharmaceutical excipient GTC has a strategic interest in developing rhSA in the excipient market with the potential for commercial sales within the next few years. The joint venture structure allows the development of the excipient market by GTC and has the potential to attract additional marketing or strategic partners that may also assist with the financing of the joint venture. These statements speak only as of the date of this document, and the Company undertakes no obligation to update or revise the statements, except as may be required by law. www.transgenics.com /pressreleases/pr010203-2.html   (662 words)

Cargill-Cerestar unveils new excipient at CPhI Cargill-Cerestar is to unveil a new excipient developed on the back of a directly compressible excipient platform that allows tablets to be produced using lower compression forces. C*PharmMannidex DC is a mannitol-based excipient which enables customers to formulate tablets with higher doses of active ingredients. This is useful where customers are increasing their use of starch-based excipients that are not animal derived. www.in-pharmatechnologist.com /news/ng.asp?n=63173-cargill-cerestar-excipient-mannitol-based   (344 words)

Auditors This will be a full-day comprehensive workshop devoted to excipient GMP auditing techniques. It is intended for pharmaceutical and chemical company auditors who assess GMP compliance practices of excipient manufacturers. The workshop will conclude with a review of compliance issues and their potential impact to satisfactory GMP compliance. www.ipeainc.com /workshop.htm   (118 words)

Pharmalicensing.com: Excipient Free - Pulmonary Drug Delivery Technology for Peptide Formulations and ultrafine drug ... Excipient Free Pulmonary drug delivery technology including a novel fluidized bed design and a novel dry powder peptide or small molecule inhaler to accurately handle, meter and administer small quantities of ultra fine powder formulations Micro Fine, No Excipient Dry Powder Small Molecule or Peptide Inhaler (Ref: UWO-AA-012): A novel DPI design that can precisely dispense amounts as small as 0.02 mg of small molecule or peptide dry powder formulations with an accuracy of +/- 5%, without requiring the use of excipients. With a DPI, the particle velocity is controlled by the patient's breath unlike for metered dose inhalers that emit medication under prssure and at high speed. pharmalicensing.com /licensing/displicopp/3420   (554 words)

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