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Albuquerque T.,IPCB Dep. Engineering Civil | Dias V.H.,University of Lisbon | Poellinger N.,Glatt GmbH | Pinto J.F.,University of Lisbon
European Journal of Pharmaceutics and Biopharmaceutics | Year: 2010

The production of granules by wet granulation in a fluidized bed was assessed after the construction of a quality index based on a file of attributes (relevant factors). These attributes are combined by a methodology relying on Correspondence Analysis, as a discriminant procedure, using two extreme simulated active vectors representing, respectively, the best and the worst cases for the granules quality output (" bad" and " good" pole). From those, a single continuous synthetic variable - the quality index - can be produced referring to a more significant set of samples. As an application of the methodology, the work compares the quality of granules produced at a laboratory scale and a pilot scale. The factors contribution to the bad or good pole allowed the identification of the most relevant factors that affect the quality of the granules. The factors studied, according to a center of gravity design, included formulation (solubility of a drug, different grades of polyvinylpyrrolidone, the polarity of the granulation solution) and processing factors (the rate of administration of the granulation solution, the atomizing air pressure and the fluidizing air rate). Granules were evaluated for production yield, drug content, size, densities (true, bulk and tapped), friability, flowability and compressibility. The study has emphasized the differences between the laboratory and pilot scales and the relative importance of each factor for the quality of the granules produced. © 2010 Elsevier B.V.


Guhmann M.,University of Greifswald | Guhmann M.,Glatt GmbH | Thommes M.,Heinrich Heine University Düsseldorf | Gerber F.,Glatt GmbH | And 5 more authors.
Pharmaceutical Research | Year: 2013

Purpose: Design of biorelevant test setups mimicking the physiological conditions experienced by drugs after oral administration along the passage through the mouth and the GI tract for the in vitro evaluation of diclofenac exhibiting multiple-peak phenomenon during absorption. Methods: The biorelevant models simulated successively saliva (SSF, pH 6.2-6.75-7.4, 5 mL, 3 min), gastric (SGF-FaSSGF, pH 1.2-1.6, 50-250 mL, 30 min) and intestinal (FaSSIF, pH 6.8, 250 mL, 60 min) fluids. Applying these models, diclofenac free acid and its sodium/potassium salt were comparatively evaluated for dissolution and further characterized by HPLC, optical morphogranulometry, DSC and PXRD to elucidate peculiar behaviors. Results: Diclofenac salts almost completely dissolved in SSF and showed a transitional dissolution pattern before complete precipitation in SGF/FaSSGF. This peculiar pattern correlated with simultaneous chemical modification and formation of agglomerates. With low dissolution in SSF and almost immediately complete precipitation, these behaviors were not observed with diclofenac free acid. Distinct diclofenac features were strongly determined by pH-modifications after oral administration. Conclusions: The multiple-peak phenomenon observed after administrating a solution, suspension or dispersible formulation of diclofenac salts are likely caused by drug precipitation and agglomeration in the stomach leading to irregular gastric-emptying. Diclofenac free acid may provide more reliable in vivo features. © 2013 Springer Science+Business Media New York.


The invention relates to a catalytically active porous element and to a method of manufacturing same. The element is formed with at least 40% by mass cobalt and at least one further chemical element and/or at least one chemical compound which form a matrix into which particles of pure cobalt, of a cobalt alloy or of an intermetallic phase formed with cobalt are embedded. In this respect, the at least one chemical element and/or the at least one chemical compound have a lower sintering temperature and/or melting temperature than cobalt, the respective cobalt alloy or the intermetallic phase. Solely for this purpose or in addition thereto, cobalt can be partially soluble therein and/or can form a eutectic and/or a peritectic together with cobalt.


Patent
Glatt Ag | Date: 2013-03-26

Taste-masked Ibuprofen granules and a process for preparation thereof, as well as an oral dosage form including such taste-masked Ibuprofen granules and the use of said granules in an oral dosage form.


In the method in accordance with the invention of manufacturing an open-cell body from a metal or ceramic material, a procedure is followed such that individual parts of an open pore plastic in a size which corresponds to the size of the bodies to be manufactured while taking account of the shrinkage on a sintering or an open pore plastic element having predetermined break points which take account of the size and geometrical design of bodies to be manufactured while considering the shrinkage in the sintering are/is infiltrated and coated with a suspension in which, in addition to a liquid, at least one powdery material is contained with which the bodies are manufactured. Organic components are expelled after a first heat treatment. Subsequently, a sintering is carried out in which open-cell bodies are obtained, wherein the parts of porous plastic provided with the suspension are separated before the first heat treatment and/or sintering or wherein, after the sintering, the open-cell element which is obtained from the plastic element from the material with which the bodies are formed is cut by forces acting at the desired break points and thereby bodies can be obtained which are present in separated form.


A pharmaceutical composition is described which includes diclofenac as an active ingredient. The pharmaceutical composition further includes a (meth)acrylic polymer which has a specific solubility and/or a particular functional group in one polymer component.


The invention relates to a method for producing particles with a length-width ratio of less than about 1.4 from a pharmaceutical substance, which method includes the following stages, that is: (a) provision of a melt of the pharmaceutical substance; (b) production of droplets of the melt by spraying into a processing chamber; (c) repeated guiding of solid particles past sprayed droplets in the processing chamber with the aid of a process gas jet which is guided in a defined way and whose temperature is fixed, depending on the solidification point of the melt, so that at least some of the droplets come into contact with particles and solidify thereon; (d) removal of particles from the processing chamber as a function of the particle size. The invention further relates to particles of pharmaceutical substances and the use thereof.


The invention relates to a method for producing particles with a length-width ratio of less than about 1.4 from a pharmaceutical substance, which method includes the following stages, that is: (a) provision of a melt of the pharmaceutical substance; (b) production of droplets of the melt by spraying into a processing chamber; (c) repeated guiding of solid particles past sprayed droplets in the processing chamber with the aid of a process gas jet which is guided in a defined way and whose temperature is fixed, depending on the solidification point of the melt, so that at least some of the droplets come into contact with particles and solidify thereon; (d) removal of particles from the processing chamber as a function of the particle size. The invention further relates to particles of pharmaceutical substances and the use thereof.


Grant
Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH-2011.4.2-1 | Award Amount: 5.52M | Year: 2011

The aim of TAIN is to develop a neonatal formulation of hydrocortisone, a drug included in the EMA priority list that needs specific evaluation in the age range 0 2 years (neonates & infants). Hydrocortisone is an essential glucocorticoid hormone used as replacement therapy for the treatment of congenital and acquired adrenal insufficiency as well playing an important therapeutic role in oncology in infants, specifically brain tumours and leukaemias. TAIN involves European leaders in neonatology, paediatric pharmacology, methodology and SMEs that will establish links with ethical bodies and regulatory authorities. The programme will perform in silico experiments and evaluate formulations for neonates. The phase 3 clinical trial comparing the neonatal hydrocortisone versus current (unlicensed) therapy will be optimized using age-appropriate state-of-the-art methods adapted to neonates (including in silico experiments and pharmacokinetics) to validate the components of a Paediatric Investigation Plan. It will be performed by neonatologists trained in paediatric pharmacology and clinical research in line with guidelines on Good Clinical Practice. All the ethical issues will be considered, including pain and distress, blood sampling (number and volume) and informed consent. Parent information sheets and consent form will be submitted to patient and parents associations for approval. TAIN will include short term safety studies and Phase 3 clinical studies in neonates and infants. Results will be reported in order to allow a PUMA application to be submitted and to improve neonatal and infant care. Therefore, TAIN will validate the appropriate use of hydrocortisone in neonates and infants which will be of direct benefit to children, their families and health professionals. TAIN will strengthen paediatric drug evaluation across Europe and build up a network of units with experience in clinical research that will be used for additional drug evaluation in neonates.

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