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Guidance on Drug Substance Particle Size Controls for

07/09/2018· Drug substance particle size is a critical property affecting drug product performance. Smaller particles dissolve faster and may improve bioavailability of the drug as a result. Smaller particles are typically dispersed more uniformly, leading to lower inter-tablet potency variation. Unfortunately, smaller particles can also result in poor powder handling characteristics or other processing issues.

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Micron-size drug particles: common and novel

Drug powders containing micron-size drug particles are used in several pharmaceutical dosage forms. Many drugs, especially newly developed substances, are poorly water soluble, which limits their oral bioavailability. The dissolution rate can be enhanced by using micronized drugs. Small drug particles are also required in administration forms, which require the drug in micron-size size due to geometric

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Towards Integrated Drug Substance and Drug Product

A novel experimental approach describing the integration of drug substance and drug production design using particle engineering techniques such as sonocrystallization, high shear wet milling (HSWM) and dry impact (hammer) milling were used to manufacture samples of an active pharmaceutical ingredient (API) with diverse particle size and size distributions. The API instability was

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Effect of Drug Active Substance Particles on Wet

01/01/2007· The effect of the size and shape of drug active substance particles on wet granulation has been studied. Active substances delivered by two different producers and active substance sampled from upper and lower levels of a storage container were used in pilot-plant experiments. There were marked differences in particle size and shape according to bulk and tapped densities, sieve and

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Effect of drug substance particle size on the

Particle agglomeration behavior was affected by drug substance particle size. Granulation geometric mean diameter and fraction with particle size greater than 250 μm was inversely proportional to the drug substance particle size. Mercury intrusion porosimetry revealed higher pore volumes for the granules manufactured using the drug substance with the smaller particle size, suggesting lower

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ICH Guidelines on particle properties

By Particle Analytical ApS. Agern Allé 3, DK-2970 Hørsholm, Denmark. Analysis of particle properties of a drug substance is required in order to understand and control the drug product. When developing a new drug product you want to make sure that it is stable during storage for a certain period (usually some years).

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PARTICLE CHARACTERISATION IN EXCIPIENTS, DRUG PRODUCTS

Particle size of drug substances and pharmaceutical excipients have an influence on chemical and physical behaviour. Particle size is therefore relevant for the behaviour of powders, granulates, creams, emulsions, liquids, etc. in relation to: • Bioavailability • Flowability • Adhesive strength • Drying properties • Solubility • Filterability • Thermal conductivity Size analysis

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Particle Characterization in the Pharmaceutical Industry

An excipient is an inactive substance used as a carrier for the active ingredients of a medication. In addition excipients can be used to aid the process by which a product is manufactured. Two common excipients magnesium stearate and microcrystalline cellulose were used as the samples for the wet and dry method development application notes. The LA-960 data shown below indicates the high

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Particle Control in Biopharmaceuticals

Particle Control in Biopharmaceuticals Successful drug product development should integrate formulation, manufacturing process, primary packaging, device and delivery to the patient. Lonza’s Drug Product Services (DPS) offering delivers a holistic approach to DP devel-opment that anticipates and prevents problems early, and ensures the result is a product that is fit for purpose. Changing

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Physical chemical characterization of drug substances

01/10/1997· Most, though not all, drug substances are solids at room temperature, and therefore this review will be concerned primarily with the characterization of substances that are solids at room temperature. In most sections specific examles have not been included because over the past ten years comprehensive reviews have been written about most examples, and justice could not be done to

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Effect of drug substance particle size on the

Particle agglomeration behavior was affected by drug substance particle size. Granulation geometric mean diameter and fraction with particle size greater than 250 μm was inversely proportional to the drug substance particle size. Mercury intrusion porosimetry revealed higher pore volumes for the granules manufactured using the drug substance with the smaller particle size, suggesting lower

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Particle engineering at the drug substance, drug product

(2019). Particle engineering at the drug substance, drug product interface: a comprehensive platform approach to enabling continuous drug substance to drug product processing with differentiated material properties. Drug Development and Industrial Pharmacy: Vol. 45, No. 4, pp. 521-531.

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PARTICLE CHARACTERISATION IN EXCIPIENTS, DRUG PRODUCTS

Particle size of drug substances and pharmaceutical excipients have an influence on chemical and physical behaviour. Particle size is therefore relevant for the behaviour of powders, granulates, creams, emulsions, liquids, etc. in relation to: • Bioavailability • Flowability • Adhesive strength • Drying properties • Solubility • Filterability • Thermal conductivity Size analysis

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Particles of drug substance, method of their production

The inventive dispersible particles consisting mainly of a crystalline drug substance adsorbed on its surface with a surface modifier in an amount sufficient for maintaining an effective average particle size of less than 400 nm, methods of obtaining such particles and a dispersion containing the particles, pharmaceutical compositions containing such particles have high bioavailability and are

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Novel drug delivery particles use neurotransmitters as a

Novel drug delivery particles use neurotransmitters as a 'passport' into the brain. by Tufts University. A successful transfer of Cre-recombinase packaged in an NT-lipidoid-doped lipid

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A method of obtaining particles of drug substance

As a medicinal substance use diagnostic contrast agent image, for example ethyl-3,5-bisceted-2,4,6-triiodobenzoate. The method involves the reduction of unacceptable extraneous impurities in drug particles. 10 C.p. f-crystals, 1 table. The invention relates to the field of grinding pharmaceutical substances.

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Justification of Drug Product Dissolution Rate and Drug

Justification of Drug Product Dissolution Rate and Drug Substance Particle Size Specifications Based on Absorption PBPK Modeling for Lesinurad Immediate Release Tablets Mol Pharm. 2016 Sep 6;13(9):3256-69. doi: 10.1021/acs.molpharmaceut.6b00497. Epub 2016 Jul 27. Authors

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Visible Particles in Injectable Drug Products and Their

06/04/2017· Particles of varying sizes have been observed in inject-able drug products, such as visible and sub visible. The particles of 1-50 Micron size are known as sub visible particles and particles of

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PARTICULATE IDENTIFICATION Particle Identification for

Bukofzer S, Ayres J, Chavez A, et al. Industry perspective on the medical risk of visible particles in injectable drug Products, PDA J Pharm Sci and Tech 2015;69:123-139. 4. United States Pharmacopeia (USP) General Chapter <1790>, “Visual Inspection of Injections.” 5. DiGrado CJ. Panel discussion: liquid-borne particle counting in the pharmaceutical industry. III. Method evaluation. Bull

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IMPURITIES IN EW DRUG SUBSTANCES Q3A(R2)

new drug substance at a level greater than (>) the identification threshold given in Attachment 1 (e.g., calculated using the response factor of the drug substance) should be described. Note that any impurity at a level greater than (>) the identification threshold in any batch manufactured by the proposed commercial process should be identified. In addition, any degradation product observed

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