Semi-Solids
Groupe PARIMA develops and manufactures semi‑solid drug products.
SEMI-SOLID DEVELOPMENT AND MANUFACTURING
CONSISTENT PERFORMANCE AT EVERY SCALE
Semi-solid drug products require careful control of formulation composition, process parameters, and product attributes to maintain consistent performance through scale-up and commercial manufacturing. Groupe PARIMA combines process understanding, fit-for-purpose analytical methods, and disciplined GMP execution to support robust and reproducible manufacturing.
Performance that holds at scale
Consistency at scale depends on controlling the process conditions that define semi‑solid performance. We combine process understanding, targeted analytical support, and disciplined documentation to support scale-up, validation, and reliable commercial manufacturing.
CONSISTENT PERFORMANCE AT SCALE
We define and control process parameters during scale-up that influence rheology, uniformity, and other critical product attributes.
LIFECYCLE CONTROL STRATEGY
Using QbD principles, we establish control strategies based on product and process understanding to support consistent performance throughout the product lifecycle.
IN‑VITRO RELEASE TESTING
IVRT methods using Franz diffusion and enhancer cells to assess performance and comparability.
Scalable processes by design
We use QbD from the start to define CQAs, identify CPPs affecting viscosity, uniformity, and API release, and build a scalable process supported by the right documentation.
Formulation Robustness
We assess formulation robustness that includes product–packaging compatibility studies to identify potential interactions that may affect product stability or performance. We also support extractables and leachables studies where required.
Critical Quality Attributes
We ranslate target product profile into CQAs that matter most for semi-solids, such as consistency, uniformity, stability, and performance-relevant characteristics.
Critical Process Parameters
Our team identifies process parameters that influence viscosity behavior, uniformity, and API release, with specific attention to mixing and filling conditions.
Consistency across the lifecycle
Groupe PARIMA applies control strategies to maintain consistent semi‑solid process and product performance throughout the lifecycle and support process validation and routine production.
Establish a scalable process
We define a reproducible process suitable for clinical, exhibit, and commercial production, supported by fit-for-purpose analytical methods aligned with semi-solid scale-up.
Dosage Form capabilities
Groupe PARIMA applies dosage-form-specific development and manufacturing capabilities to keep critical attributes consistent as scale-up, equipment, and demand evolve.
Cream
We develop oil-in-water and water-in-oil creams using high-shear homogenization, validated for viscosity, droplet size, and phase stability across shelf life.
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Emulsion stability under temperature cycling.
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Homogeneous distribution of poorly soluble APIs.
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Optimization of pH and preservative systems for microbial protection.
Ointment
We develop ointments with controlled API solubilization or dispersion and consistent texture and in vitro permeation testing as needed.
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Choose the right oleaginous or absorption base.
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Resolve issues with API sedimentation or crystallization.
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Minimize grittiness and ensure consistent texture and application profile.
Lotion
We develop lotions with controlled flow properties and stable emulsions, using a scale-ready approach that maintains uniformity through optimized mixing, shear, and cooling profiles.
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Enhance spreadability without compromising API stability.
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Select non-irritant emulsifiers and humectants for sensitive applications.
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Ensure physical stability and microbial robustness in low-viscosity systems.
Gel
We develop gels with highly sensitive to formulation conditions such as polymer level and pH, which is why control matters early. Our team applies IVRT to support formulation optimization and strengthen decision-making.
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Select gelling agents based on viscosity and drug release.
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Resolve API-polymer interactions that may impact clarity or stability.
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Ensure batch-to-batch rheological consistency using detailed viscosity and texture analysis.
Our Services
We connect development, analytical support, and GMP execution to manage semi-solid variables proactively and keep timelines moving.
Product Development
Manufacturing-ready development that reduces rework later, with decisions that scale as requirements increase.
Analytical Services
Clear data for decision-making stability plans, and confident release as your program progresses.
Manufacturing & Packaging
Consistent execution designed for predictable release and routine supply, with controlled changes over time.
We ensure semi-solid shelf life by controlling key risk drivers from day one, tightening process controls, and confirming performance through fit-for-purpose stability studies.
Resources
Access practical guidance on semi-solid development and manufacturing that affects shelf life.