Semi-Solids
Experts in the Formulation, Scale-up, and Commercial Manufacturing of Semi-Solid Drug Products
Semi-solid products, such as lotions, creams, ointments, and gels, are complex topical products, and small changes in excipients or process conditions can significantly alter their microstructure, drug release, skin penetration, and long-term stability. CPL excels at semi-solid formulation development, optimizing API solubility and stability, excipient selection, rheology, release, and permeation while managing emulsion stability, preservative effectiveness, packaging interactions, and seamless scale-up to commercial volumes for products at every stage of development and commercialization.
Integrated Semi-Solid Development, Skin Testing, and GMP Manufacturing
As a pure-play CDMO specializing in semi-solid drug products, including creams, lotions, ointments, and gels, we have extensive experience designing topical formulations to overcome API deliverability and stability challenges, selecting the optimal product dosage form, and tightly controlling rheology, drug release, and skin permeation from the earliest stages of product and formulation development.
Formulation & Analytical Expertise
Our formulation and analytical teams work side by side, using Design of Experiments, robust analytical method development, and ICH-aligned method validation to create semi-solids that are both efficacious and of the utmost quality. Products are tested for uniformity, homogeneity, viscosity, rheology, texture analysis, and more. Additionally, our Skin Lab scientists perform in vitro release and permeation testing for formulation screening and equivalency.
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Manufacturability, Process Development & Tech Transfer
Process development supporting manufacturability is embedded from day one. We map Critical Process Parameters (CPPs) to Critical Quality Attributes (CQAs), optimize conditions to design processes that scale seamlessly from the lab to commercial production. For tech transfer programs, we de-risk the effort by conducting structured gap and risk analyses, running lab and pilot batches, and performing compatibility and scale-up studies.
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Semi-Solids Clinical & Commercial Manufacturing
CPL’s 140,000 ft2 GMP manufacturing facility supports clinical and commercial semi-solid production from 20kg to 5,000kg, with integrated packaging in tubes, bottles, and sachets. We produce clinical, registration, and commercial batches under rigorous cGMP, execute process validation, and maintain strong OTIF performance, delivering semi-solid products that are scientifically sound, scalable, and supply-chain ready.
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Skin Testing Services
CPL’s Skin Lab provides in vitro skin testing that helps formulate topical and transdermal products. Using IVPT to measure permeation, IVRT to quantify drug release, and drug distribution in skin layers, we generate rapid, high-value data without relying solely on costly in vivo studies. Formulators and Skin Lab scientists work in close partnership, using these insights to refine formulations and process parameters, support bioequivalence understandings, and build regulatory-ready packages for topical, semi-solid drug products.
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Microencapsulation for Challenging Drug Delivery
CPL specializes in microencapsulation, integrating liposomes into semi-solid matrices to enhance topical drug delivery. Using high-pressure homogenization, microfluidics, and in vitro skin testing, we optimize loading, release, and penetration while seamlessly scaling from lab to commercial manufacturing.
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Packaging, Labeling & Serialization
CPL is more than another manufacturer of bulk drug product. Our packaging, labeling, serialization, and aggregation capabilities provide turnkey manufacturing and packaging solutions that increase efficiency, reduce risks, and ensure compliance with the latest supply chain and traceability requirements.
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Accelerated Semi-Solid Drug Development
Dedicated to Excellence
from Molecule to Commercialization
CPL supports programs from early-phase through commercial launch, combining preformulation insight, robust semi-solid and non-sterile liquid development, scalable process design, and clinical and commercial manufacturing.
Pharmaceutical Development Services
Pharmaceutical Development Services
Comprehensive expertise that turns molecules into scalable, compliant, market‑ready semi-solid and non-sterile therapies.
Analytical & Product Testing
Analytical & Product Testing
Robust analytics power confident development and manufacture of topical and non-sterile liquid products.
Clinical & Commercial Manufacturing
Clinical & Commercial Manufacturing
More than three decades of GMP manufacturing experience from clinical supply through commercialization.
Packaging, Labeling & Serialization
Packaging, Labeling & Serialization
Integrated packaging, serialization, and aggregation ensure compliant, continuous commercial supply.
Semi-Solid & Non-Sterile Liquid Expertise
Semi-Solid & Non-Sterile Liquid Expertise
Pure-play CDMO for semi-solids and non-sterile liquids, with advanced micro encapsulation capabilities.
Unique Product Handling Experience
Unique Product Handling Experience
Infrastructure and expertise to manage complex, higher-risk semi-solid and non-sterile liquid products.
FAQs
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Semi-solid dosage forms are structured systems, typically emulsions, where oil and aqueous phases are combined to create creams, ointments, gels, and lotions with defined rheology for spreadability and drug release.
CPL develops and manufactures Rx, generic, and OTC semi-solid topical products, optimizing API solubility and stability, carrier selection, and skin permeation from early formulation through commercial GMP manufacturing.
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Semi-solids must deliver the drug product precisely to the target skin layer while remaining physically and chemically stable throughout their shelf life. Controlling rheology, microstructure, and emulsion or suspension stability is critical for dose uniformity and product performance.
Regulators also expect robust strategies for scale-up and post-approval changes, making in vitro release testing (IVRT) and tight control of critical process parameters essential.
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In vitro release testing (IVRT) measures drug release for semi-solids and is referenced in FDA SUPAC-SS guidance as a key tool for scale-up, site transfer, and post-approval changes. In vitro permeation testing (IVPT) quantifies permeation rates and drug distribution within the skin layers, which enables formulation optimization. CPL’s Skin Lab integrates IVRT, IVPT, and skin distribution studies to rank prototypes, troubleshoot penetration issues, and generate regulatory-ready data.
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Scaling semi-solids from lab to plant is complex because changes in process parameters or the order of API and excipient addition can alter CQAs, triggering product quality and regulatory concerns.
CPL embeds manufacturability early by mapping CPPs to CQAs, performing robust scale-up studies, and aligning process development with process validation and potential post-approval changes.
Commitment.
Partnership. Legacy.
Leverage CPL’s 35 years of expertise in non-sterile liquids and semi-solids to ensure your program's success. We’ll support your product from molecule to market, or step in at any stage of its product lifecycle.
