Solid State Characterization Of Pharmaceuticals
In recent years, high throughput screening has facilitated form selection at an early stage. Early polymorph screening identifies and selects the best forms s for further evaluation.
Enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes. Many compounds can exist in multiple crystal forms, i. Inspection Validating the specifications, value and safety of your raw materials, products and assets. Properties of solid drugs impact on all stages of drug development, from synthesis to production of clinical supplies. In these systems, an excipient carrier stabilizes the amorphous drug within the formulation matrix, helping to retard crystallization.
Solid State Characterization
An extreme example is the drug ritonavir, where late stage appearance of a new, more stable polymorph compromised product performance i. Assurance Testing Inspection Certification. As an example, atorvastatin is acid labile while aspirin undergoes alkaline hydrolysis. Acids or bases can also be converted to salts, offering an additional option to improve solubility. Besides solubility, physical and chemical stability of solid drug forms must be adequately characterized.
Conclusion Properties of solid drugs impact on all stages of drug development, from synthesis to production of clinical supplies. This is particularly true when a solid drug is delivered in tablets or capsules, but also relevant to other dosage forms such as suspensions and powders. These can lead to physical defects and dissolution problems, culminating in product failure. Need help or have a question? Finally, properties of the solid drug can influence how it is packaged and stored i.
Sample Submission Guidelines. During manufacture, a solid drug is exposed to multiple processes on its way to a finished product. Monoclonal Antibody Structural Characterisation Challenges. An amorphous drug product was deliberately produced by injection molding, resulting in a solid dispersion.
Assurance Enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes. Validating the specifications, value and safety of your raw materials, products and assets. Understanding and preventing crystallization of amorphous solid formulations e. Particle Sciences transforms your discovery into a clinic-ready product. This salt demonstrated good water solubility, but on occasion haziness was observed when the drug substance powder was reconstituted in aqueous solution.
Amorphous drugs are attractive for solubility enhancement, but are inherently unstable and pose special challenges for formulation due to chemical reactivity and hygroscopicity. Polymorphs Many compounds can exist in multiple crystal forms, i. Dexamethasone-Loaded Silicone for Implantable Systems. Reduction of particle size through milling or micronization increases specific surface area, leading to enhanced dissolution and improved homogeneity of the bulk material. These studies also highlight a few of the techniques available for sample analyis.
Salt screening is frequently done in discovery to identify the best form s for development. Auditing Consulting Sourcing Training. About Us Management Team Employment.
Our experience in solid state characterisation and formulation development will help to optimise your solid dose pharmaceutical product. Solid state characterisation of pharmaceuticals, determining physical properties such as particle size, polymorph and morphology of solid dose forms. Nanotechnology Characterisation Download our recent interview with Intertek experts on the characterization of nanomaterials in healthcare products. Case Studies Selected case studies are presented as examples of solid drug characterization. Selected case studies are presented as examples of solid drug characterization.
These physical properties can have an impact on the material's bulk properties, formulation performance, processability, stability and appearance. Screening involves recrystallization of the drug from a variety of solvents under different conditions. There is considerable interest in combination tablets as a way to overcome the incompatibility between certain drugs.
However, this does not replace the need for more detailed investigations of form stability. Another useful property is the partition coefficient logP, which describes drug partitioning between aqueous and organic phase. Nanomilling Feasibility Program.
Formulation Considerations During manufacture, a solid drug is exposed to multiple processes on its way to a finished product. In addition to polymorphs, solvated or hydrated drug crystal forms can exist, sometimes referred to as pseudopolymorphs. With respect to the latter, physical stability knowledge is equally important.
Counterions and crystallization solvents are exposed to a number of preparation conditions. Coating of one or both actives affords additional protection from degradation. Some common physical forms of solid drugs are summarized below.
Rational choice of excipients for solid dosage formulation is critical, and is supported through compatibility experiments conducted during preformulation. To accomplish this, solids are subjected to stresses heat, humidity, light and analyzed. Stability Besides solubility, telugu punch dialogues mp3 physical and chemical stability of solid drug forms must be adequately characterized.
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