Pharmaceutical Formulation Development
From API to Drug Product!
Avivia supports pharmaceutical companies with formulation development from early feasibility to product optimization and preparation for scale-up or small-scale GMP manufacture.
Our formulation capabilities are tightly integrated with in-house analytical R&D, dissolution testing and excipient characterization. This allows us to design, screen and troubleshoot formulations with a practical focus on bioavailability, stability, manufacturability and product performance.
As an independent development partner, we can help define the most suitable formulation strategy and select the appropriate manufacturing route or external manufacturing partner for the product.
Avivia supports both new and existing drug products, from early formulation feasibility and preclinical prototypes to formulation optimization, complex drug delivery systems and preparation for manufacturing. Projects can be performed as focused problem-solving studies or as integrated development programs combining formulation, analytical development, dissolution testing, stability and transfer to GMP manufacture.
Discuss your formulation development project
Avivia provides integrated pharmaceutical R&D services in formulation, analytical development, dissolution and excipient analysis.
What we support
- Early formulation strategy, feasibility studies and preclinical prototype development
- Conventional oral formulations including tablets, capsules, powders, solutions and suspensions
- Parenteral and injectable formulation development
- Solubility and bioavailability enhancement for poorly soluble or poorly absorbed APIs
- Modified-release, controlled-release and long-acting formulation development
- Alternative routes of administration including nasal, buccal, topical, ocular and rectal delivery
- Excipient selection, API–excipient compatibility and excipient functionality assessment
- Generic and hybrid drug product development based on reference-product characterization
- Reformulation, formulation optimization and pharmaceutical troubleshooting
- Integrated analytical development, dissolution/release testing and stability support
- Process development, scale-up and transfer to small-scale GMP or external manufacturing
Formulation Development for Different Drug Product Challenges
Poorly Soluble APIs and Bioavailability
Poor aqueous solubility, limited dissolution or insufficient absorption can prevent an otherwise promising API from becoming a viable drug product. Avivia evaluates the physicochemical properties of the drug substance together with the intended route of administration and target product profile to select practical formulation strategies. Depending on the development question, approaches may include particle-size reduction, amorphous or solid-dispersion strategies, solubilization, cyclodextrins, lipid- or surfactant-based systems, nanosuspensions, permeation enhancement and other formulation technologies. Formulation screening can be combined directly with analytical and dissolution testing to determine whether an approach actually improves product performance.
Modified, Controlled and Long-Acting Release
Avivia develops formulations in which the release profile is itself an important product characteristic. Projects can range from modified-release oral dosage forms to depot injections, microspheres and other long-acting or locally controlled drug-delivery systems. Formulation development is closely linked to dissolution or in-vitro release testing so that the influence of formulation composition, excipient properties, processing and release mechanism can be investigated during development rather than evaluated only after a prototype has been selected.
Parenteral and Alternative Routes of Administration
Not every API or therapeutic objective is best served by a conventional oral dosage form. Avivia has hands-on formulation experience with parenteral products and alternative routes including nasal, buccal, topical, ocular and rectal delivery. Development considerations depend on the route and may include solubility, pH, osmolality, viscosity, excipient compatibility, sterility requirements, local tolerability, release behaviour and device or packaging compatibility.
More detailed information is available on our Route of Administration page.
Generic and Reference-Product-Based Development
For generic and hybrid drug products, formulation development often starts with understanding the reference product. Avivia can combine reference-product characterization, deformulation and excipient analysis with formulation development, analytical testing and comparative dissolution. This integrated approach helps translate information about composition and product performance into a practical formulation strategy and supports iterative comparison of development prototypes with the reference product.
From Formulation Feasibility to Manufacturing Transfer
Formulation projects can start with a focused feasibility question or with a broader drug product development objective. The development program is adapted to the product, available knowledge and stage of development.
A typical program may progress through:
Feasibility and strategy → Concept formulation → Prototype screening and optimization → Analytical and dissolution evaluation → Stability assessment → Process development and scale-up → Transfer to GMP manufacture
Not every project requires every phase. Individual activities can be performed independently, while more complex programs can be managed as an integrated development project. Because formulation scientists work directly with Avivia’s analytical and dissolution teams, experimental results can be translated rapidly into the next formulation decision.
Small-Scale GMP and Manufacturing Transfer
Avivia supports the transition from formulation development to manufacturing through process development, scale-up and technology transfer. Depending on the product and development stage, this can include small-scale GMP activities or transfer to an appropriate external manufacturing partner. Formulation development is supported throughout by Avivia’s in-house analytical, dissolution and excipient-characterization capabilities, helping maintain continuity from development through transfer.
Our pharmaceutical laboratory formulation development services are supported by strong in-house analytical, dissolution and excipient characterization service platforms.
Discuss your formulation development project
Formulation Decisions Start with the Drug Substance and Target Product
Successful formulation development starts with understanding the drug substance and defining the required product performance. Relevant API properties may include solubility, pKa, solid-state form, particle size, stability, dose and permeability, considered in relation to the intended route of administration, dosage form and release profile.
Excipient selection and processing conditions are evaluated alongside these properties. Where relevant, API–excipient compatibility, excipient functionality and variability, dissolution behaviour and stability are investigated as part of formulation development. This integrated approach helps identify the factors that determine drug product performance and supports rational formulation optimization.
Avivia supports both focused formulation problem-solving and complete drug product development programs, from early feasibility and prototype development through formulation optimization, scale-up and manufacturing transfer.
Complex drug product formulations
Complex drug products often require unconventional formulation strategies. Our experience with challenging formulations and patent workarounds enables us to address difficult CMC and drug delivery problems.
Scale up and GMP
We support scale-up, process development and transfer from the R&D laboratory to GMP manufacturing, working with an established network of CMO partners to accommodate a broad range of products and technologies.
Problem solving and troubleshooting
When a formulation does not perform as expected, we combine formulation, analytical and dissolution expertise to identify the underlying cause and develop a practical solution.
Pharmaceutical Formulations
Avivia develops pharmaceutical formulations across a broad range of routes of administration and dosage forms. The appropriate approach is selected according to the drug substance, therapeutic objective, required product performance and intended patient use. The following types of formulations are available.
Route of administration
Routes: oral, parenteral, nasal, buccal/oromucosal, topical/transdermal, ocular, rectal/vaginal and other specialized routes.
Dosage forms
Dosage forms: tablets, capsules, powders, solutions, suspensions, injections, creams, gels, sprays and more specialized drug-delivery systems.
Avivia has concrete hands-on experience with the formulation development of the previously mentioned dosage forms. Interested? Get in touch with us!
Examples of Formulation Technologies and Development Projects
- 3D printing
- Silica loading
- Degradable and non-degradable systems
- Implant technology
- Controlled release coatings
- Controlled release matrices
- Abuse-deterrent formulations
- Solubility enhancement
- Amorphous solid dispersions
- SMEDDS / lipid-based approaches
- Long-acting/depot formulations
- Microspheres
- Nano-milling and nanosuspensions
- Taste masking
- Spray drying
- Alternative-route formulations
Formulation Development Equipment and Technologies
Avivia’s pharmaceutical development laboratory and flexible small-scale facilities provide access to equipment and technologies including:
• Extrusion
• Spray-drying
• Nano-milling
• Tabletting
• Encapsulation of solids and/or liquids
• Aseptic filling or sterile manufacturing of injectables (vials)
• Blending
• Granulation (high and low shear, fluid bed)
• Vacuum drying and stability cabinets
• Lyophilization
• Material matching (primary and secondary packaging)
• Terminal sterilization (e.g. autoclaving; dry heat sterilization; γ irradiation)
• Liquid- and semi-solid mixing & filling
Frequently Asked Questions
Can Avivia develop a formulation for a poorly soluble API?
Yes. Avivia develops formulation strategies for APIs where poor aqueous solubility, dissolution or bioavailability limits drug product development. Depending on the API and target product profile, approaches may include particle-size reduction, amorphous solid dispersions, cyclodextrins, lipid- or surfactant-based systems, nanosuspensions and other solubility- or bioavailability-enhancing strategies. Formulation screening can be directly combined with analytical and dissolution testing.
Can Avivia develop injectable and parenteral formulations?
Yes. Avivia supports parenteral formulation development from early feasibility and preclinical prototypes through formulation optimization and preparation for further development or manufacturing transfer. Relevant factors may include API solubility and stability, pH, osmolality, excipient selection, compatibility and the intended route of administration.
Does Avivia develop modified-release and long-acting formulations?
Yes. Avivia has experience with modified-, controlled- and long-acting drug delivery systems, including oral modified-release products, depot formulations, microspheres and other controlled-release approaches. Formulation development can be integrated with dissolution or in-vitro release testing to understand and optimize the release mechanism.
Can Avivia develop a generic or hybrid formulation based on a reference product?
Yes. Reference-product characterization can be combined with deformulation, excipient analysis, formulation development, analytical testing and comparative dissolution. This helps translate information about the composition and performance of the reference product into a practical formulation development strategy.
Can Avivia help when an existing formulation does not perform as expected?
Yes. Formulation troubleshooting can address problems such as insufficient or variable dissolution, poor stability, API–excipient interactions, manufacturing problems or unexpected product performance. Avivia combines formulation, analytical, dissolution and, where relevant, advanced excipient characterization to investigate the underlying cause and develop a practical solution.
Can formulation, analytical development and dissolution testing be performed within the same development program?
Yes. This is a core part of Avivia’s development approach. Formulation scientists work directly with analytical and dissolution scientists, allowing analytical results, dissolution behaviour and physical observations to be evaluated together and rapidly translated into formulation decisions.
At what stage can Avivia become involved in a formulation development project?
Projects can start with early feasibility or preclinical formulation development, an existing formulation requiring optimization, a reference product for generic or hybrid development, or a product approaching scale-up and manufacturing transfer. Avivia can perform individual development activities or support an integrated program from formulation feasibility through process development and transfer.
Can Avivia transfer a developed formulation to GMP manufacturing?
Yes. Avivia supports process development, scale-up and technology transfer following formulation development. Depending on the product and project requirements, development can progress toward small-scale GMP activities or transfer to an appropriate manufacturing partner.
