Porosity in pharmaceutical materials can be present in various locations: within tablet cores and granules, coatings, and within the particles of a pre-cursor powder blend and also the void spaces between powder particles. The latter dictates the porous characteristics of tableted forms. SSA measurement is routinely and usefully applied to the characterisation of powder samples but the pore sizes present commonly fall within the range measured by the mercury porosimetry technique. This provides a complete picture of pore size, pore volume, volume porosity and density. It can also provide insight to pore geometry. These porosity characteristics then dictate performance behaviours, may be indicative of atypical performance, and often change during the ageing processes applied during stability trials.
Pharmaceutical Characterisation at MCA ServicesThe physical characteristics of pharmaceuticals profoundly influence the properties and effectiveness of the final dosage form, be it administered via tablet, granule / capsule or inhalation routes. Furthermore, knowledge of physical characteristics often contributes to the critical understanding of all components, such as API, excipients, powder blends and ribbons as well as the final form. They are also applicable to all stages of pharmaceutical processes: from formulation through manufacturing to quality control, stability trials and trouble-shooting atypical behaviour. Physical characteristics commonly include specific surface area (SSA), pore size and volume distributions and density, which together provide a complete understanding of overall porosity. In turn, porosity has direct effects on many aspects of performance, for example dissolution and disintegration rates, strength and hardness and long term stability of solid dosage forms. They also influence formulation and effect stability of solid components in many emulsion, paste and topical forms.
Key ApplicationsCharacterisation of API and excipient materialsCharacterisation of powder blendsInvestigation of dissolution rateStudy of disintegrationInvestigation of batch failures and inter-batch variabilityInfluence of stability trials on porosityDetermination of long-term stability and shelf lifeInvestigation and establishment of tableting conditions Identification of counterfeit batchesSignificant to approval processesAll analyses undertaken to ISO 17025 standards
Key Analytical TechniquesMercury PorosimetryPore volume DistributionPore Size DistributionPore Area DistributionAbsolute PorosityBulk and Skeletal DensityPore GeometryPermeability MeasurementApplicable to all solid formsGas AdsorptionBET Specific Surface Area by NitrogenBET Specific Surface Area by Krypton (low SSA)Micro-pore / Meso-pore characterisationPore volume DistributionPore Size DistributionPore Area Distribution
At MCA Services we offer a suite of analytical techniques for the complete characterisation of pharmaceutical samples. This is combined with the experience and expertise to actively assist with the interpretation of results directly relating these to performance characteristics of the material. We have many years of experience partnering with the pharmaceutical sector, considering a wide variety of dosage forms and applications, from formulation to stability trials and identification of the influence of porosity to materials and batches having atypical behaviour.
MCA Services
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Pharmaceutical CharacterisationThe physical characteristics of pharmaceuticals profoundly influence the properties and effectiveness of the final dosage form, be it administered via tablet, granule / capsule or inhalation routes. Furthermore, knowledge of physical characteristics often contributes to the critical understanding of all components, such as API, excipients, powder blends and ribbons as well as the final form. They are also applicable to all stages of pharmaceutical processes: from formulation through manufacturing to quality control, stability trials and trouble-shooting atypical behaviour. Physical characteristics commonly include specific surface area (SSA), pore size and volume distributions and density, which together provide a complete understanding of overall porosity. In turn, porosity has direct effects on many aspects of performance, for example dissolution and disintegration rates, strength and hardness and long term stability of solid dosage forms. They also influence formulation and effect stability of solid components in many emulsion, paste and topical forms.
Key ApplicationsCharacterisation of API and excipient materialsCharacterisation of powder blendsDissolution rate studyDisintegration studyInvestigation of batch failures and inter-batch variabilityInfluence of stability trials on porosityDetermination of long-term stability and shelf lifeInvestigation and establishment of tabletting conditions Identification of counterfeit batchesSignificant to approval processesAll analyses undertaken to ISO 17025 standards
Porosity in pharmaceutical materials can be present in various locations: within tablet cores and granules, coatings, and within the particles of a pre-cursor powder blend and also the void spaces between powder particles. The latter dictates the porous characteristics of tableted forms. SSA measurement is routinely and usefully applied to the characterisation of powder samples but the pore sizes present commonly fall within the range measured by the mercury porosimetry technique. This provides a complete picture of pore size, pore volume, volume porosity and density. It can also provide insight to pore geometry. These porosity characteristics then dictate performance behaviours, may be indicative of atypical performance, and often change during the aging processes applied during stability trials.
Key Analytical Techniques Mercury PorosimetryPore volume DistributionPore Size DistributionPore Area DistributionAbsolute PorosityBulk and Skeletal DensityPore GeometryPermeability MeasurementApplicable to all solid formsGas AdsorptionBET Specific Surface Area by NitrogenBET Specific Surface Area by Krypton (low SSA)Micro-pore / Meso-pore characterisationPore volume DistributionPore Size DistributionPore Area Distribution
At MCA Services we offer a suite of analytical techniques for the complete characterisation of pharmaceutical samples. This is combined with the experience and expertise to actively assist with the interpretation of results directly relating these to performance characteristics of the material. We have many years of experience partnering with the pharmaceutical sector, considering a wide variety of dosage forms and applications, from formulation to stability trials and identification of the influence of porosity to materials and batches having atypical behaviour.