Preformulation Studies and Services
Effective pre-formulation studies are the most appropriate method for accelerating the product development
Preformulation studies provide a path for formulation development and drug product development in respect of drug form, adjuvants, composition, physical structure, and chemistry of drug molecules, facilitating pharmacokinetic and biopharmaceutical properties evaluation, adjustments, and their implementation to get an appropriate end product, product process development support.
API characterization Studies
API Characterization allows to speed up Drug Product Development. The active substance is the core of any formulation (the formulation is constructed around it). The physico-chemical properties of the API play a key role in how the drug is delivered. Following tests can be performed at our site and partner sites
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Particle size distribution and shape
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Bulk density
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Tapped density
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Compressibility and flowability
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Hygroscopicity
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Solid State Characterization (Crystal habit, Crystalline or amorphous through XRD/DSC)
Solublity Studies
Evaluation of the solubility of the API in one or more aqueous media with or without surfactant. Mimicking the physiological conditions and allowing to fulfil the sink conditions. Solubility study helps to decide dissolution medium for QC and bio relevant medium
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Aqueous and non-aqueous mediums
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pH Buffers
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Solubility studies in presence of Solubilizers/Excipients
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Bio-relevant Media (FaSSIF, FeSSIF and SGF)
Dissolution Studies
Dissolution testing measures the extent and rate of solution formation from a dosage form, such as tablet, capsule, ointment, etc. The dissolution of a drug is important for its bioavailability and therapeutic effectiveness. Dissolution studies helps to predict the bioequivalence. We can offer all below dissolution profiling studies
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Intrinsic
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Bio-relevant (Single & two stage)
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QC media
Force Degradation Studies
Forced degradation studies are a critical element of pharmaceutical development. Forced degradation testing helps in:
Establishing likely degradation pathways and products, Evaluating the stability of the molecule, Validating the analytical methods used to assess chemical stability, Gaining insight into drug packaging and storage.
We can offer all below force degradation studies
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Hydrolytic
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pH
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Oxidative
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Thermal
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Photo-stability
Drug Excipient Compatibility
Studying drug-excipient compatibility is essential for optimizing the stability of a dosage form, as any interaction between the drug and excipient can impact its bioavailability, stability, and safety. By identifying and mitigating potential interactions, we can prevent unexpected issues and ensure the efficacy of the medication. Our comprehensive approach includes a developability assessment to determine the most suitable formulation technology.
Additionally, we offer compatibility studies with mixtures of active pharmaceutical ingredients (API) and excipients, providing valuable insights for formulations involving binary or tertiary combinations.
Why Concresco ?
Innovative Product Development
Dosage Form Proficiency
Global Expertise
ExperiencedLeadership Team
