Pre-formulation studies are an important prerequisite for formulation process development. It provides the essential basis for evaluating the pharmacokinetics of compounds, selecting drug administration routes and dosage forms, designing prescription processes, and quality control. It is the foundation for developing safe, effective, and quality-controlled drugs.
Alta Stomatology is a company dedicated to the research and development of drugs for oral diseases. We can provide clients with comprehensive pre-formulation research services, including crystalline screening and solid-state characterization, physicochemical and biopharmaceutical property characterization of active pharmaceutical ingredients, stability studies of active pharmaceutical ingredients, compatibility studies of active pharmaceutical ingredients with excipients, and non-clinical animal dosing protocol development. Our materials science department can also characterize the physical properties of formulations to guide formulation process design, thus ensuring full lifecycle support for clients' drugs for oral diseases. If you have any needs, please feel free to contact us.
Our Services
Comprehensive Physicochemical Property Evaluation
Alta Stomatology employs state-of-the-art techniques and methodologies to conduct thorough assessments of physicochemical properties crucial for oral disease drug development. From solubility and stability studies to particle size analysis and crystallinity determination, our experts meticulously analyze the fundamental characteristics of candidate compounds. By elucidating these properties early in the development process, we empower our clients to make informed decisions and optimize formulation strategies for enhanced efficacy and bioavailability.
| pKa |
Log P/Log D |
Crystal form analysis (XRPD) |
| Crystal melting point |
Hygroscopicity (DVS) |
Particle size distribution (PSD) |
| crystal habit (PLM) |
Solubility-organic solvents |
Solubility-pH |
| Solubility-biologically relevant media (SGF, FaSSIF, FeSSIF) |
|
|
Excipient Selection and Compatibility Studies
Choosing the right excipients is paramount in formulating safe and effective oral disease medications. At Alta Stomatology, we offer comprehensive excipient selection services tailored to the specific requirements of each drug candidate. Through rigorous compatibility studies, we evaluate the interaction between active pharmaceutical ingredients (APIs) and excipients, ensuring compatibility, stability, and optimal performance of the final formulation. Our expertise enables clients to mitigate risks associated with formulation challenges and expedite the development of oral disease drugs.
| Chemical stability studies |
Physical stability studies |
| Excipient compatibility studies |
Choose the most appropriate excipient |
Animal Dosing Vehicle Selection
Selecting the appropriate dosing vehicle is crucial for preclinical studies, ensuring accurate dosing and reliable results. Alta Stomatology offers expertise in animal dosing vehicle selection, taking into account factors such as solubility, stability, and compatibility with the test compound. Our team collaborates closely with clients to identify the most suitable vehicles, optimize drug delivery, and facilitate a seamless transition from preclinical to clinical development stages.
Amorphous Solid Dispersions
Amorphous solid dispersions (ASDs) hold immense potential for enhancing the solubility and bioavailability of poorly water-soluble drugs. Alta Stomatology specializes in the development and characterization of ASDs, employing cutting-edge techniques to formulate stable and reproducible systems. Through precise control of drug-polymer interactions and dispersion methodologies, we enable the efficient delivery of oral disease medications, unlocking new possibilities for therapeutic efficacy and patient care.
Drug Developability Assessment
We conduct a detailed assessment of your drug candidate's developability to identify potential issues early in the drug development process and provide recommendations for optimization.
| BCS and DCS classifications |
Developability assessment to identify suitable formulation technology |
Why Choose Alta Stomatology?
Our team of scientists and researchers at Alta Stomatology have extensive experience in pharmaceutical research and development. We have completed numerous pre-formulation studies for a wide range of drug compounds and formulations, giving us the expertise to tackle complex formulation challenges.
Alta Stomatology is equipped with state-of-the-art equipment and technology to conduct physicochemical property evaluations, compatibility studies, and formulation development. We leverage advanced techniques to deliver accurate and reliable results that meet the highest industry standards.
We understand that each drug compound has unique characteristics and requirements. At Alta Stomatology, we provide personalized services tailored to the specific needs of our clients.
We understand the importance of meeting project timelines and deadlines. At Alta Stomatology, we prioritize efficiency and timeliness in delivering pre-formulation services to our clients. Our streamlined processes and proactive communication ensure that projects are completed on schedule without compromising quality.
For research use only. Not
intended for any clinical use.
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