Oral solid dose
Achieve success in oral solid dose early development to ensure scalability
Due to the need to reach patients with speed and agility, companies are evolving the ways they plan and execute the development and manufacturing of oral solid dose (OSD) drug products. We provide a range of early development OSD solutions that can address your small molecule’s unique needs and challenges, while being backed by technical experts to quickly advance your molecule to the next phase.
60-70%
Sixty to 70% of molecules in clinical development have high permeability but poor solubility; predictive modeling can help
78%
We are involved with 78% of the top-performing drug products, delivering reliability and quality
>230
We worked on more than 230 active pharmaceutical ingredients (APIs) for large and small molecules in 2020
3 of the top 8
We have developed and launched 3 of the top 8 best-selling small molecule drugs
60-70%
Sixty to 70% of molecules in clinical development have high permeability but poor solubility; predictive modeling can help
78%
We are involved with 78% of the top-performing drug products, delivering reliability and quality
>230
We worked on more than 230 active pharmaceutical ingredients (APIs) for large and small molecules in 2020
3 of the top 8
We have developed and launched 3 of the top 8 best-selling small molecule drugs
Oral solid dose solutions and capabilities
Getting formulation right from the start of early development can help save time and money as you advance through each phase and onward to commercialization. Our early development formulation experts and scientists are here to support every step of your project to:
- Accelerate your project to first-in-human (FIH) studies
- Rapidly characterize your drug substance
- Quickly evaluate formulation options
- Overcome formulation challenges such as low bioavailability
- Pave the way for preclinical and clinical studies
- Design, validate, and implement analytical and process methodologies
- Generate the data required for IND filings
Predictive Modelling (Engineered Solutions)
Reduce the risks associated with trial-and-error experimental methods.
Solve solubility and bioavailability challenges before they become long-term issues.
Poorly soluble compounds often demonstrate lower bioavailability, which can reduce the efficacy of the drug substance or product. Leveraging Patheon™ Quadrant 2™ predictive modeling helps in early formulation development by in-silico predictions of formulations. This approach saves time and costs by avoiding empirical, more traditional trial-and-error approaches. Quadrant 2™ predictive modeling analyzes the molecular structure, physical, and chemical characteristics of a compound and predicts the solubility enhancement technology and excipient combination that are most likely to succeed.
Our suite of predictive modeling tools also includes:
- Accelerated stability testing: Predict product shelf life and packability stability
- Process development (material blending and compaction behavior): Understand material behavior and the impact on process development
- Predicting API physicochemical properties and pharmacokinetics: Gain an early understanding of how your product is metabolized
Helpful resources
Access to a wide range of conventional and specialized dosage forms, from simple to complex, can enable an integrated drug formulation program that is customized to your molecule’s unique properties. We will work with you to ensure that your discoveries have a proof-of-concept that has speed and efficiency built in to accelerate your molecule’s journey to FIH studies.
Our formulation scientists have access to a wide variety of technologies and approaches to control the release of the active ingredient. When working with Patheon pharma services, you will have access to a broad selection of dosage forms and release profiles such as:
- Highly regulated products
- Pediatric tablets
- Capsules
- Softgel technologies
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Our scale-up solutions will give you access to a risk assessment and proven acceptable range (PAR) studies, as well as validation of analytical methods and the manufacturing process. If needed, our QA and regulatory compliance team can provide data and support for the Chemistry, Manufacturing, and Controls (CMC) portion of your submission. Active pharmaceutical ingredients (API) for use in clinical trials are produced at state-of-the-art manufacturing facilities in Europe and North America. All our facilities comply with Current Good Manufacturing Practice (cGMP) regulations and are regularly inspected by national regulatory agencies.
A team of experts will surround your discovery with a full range of technologies and analytical services to allow the highest degree of flexibility and deliver on time, with exceptional yields and superior quality. In late-stage trials and beyond, your drug substance will be manufactured at a cGMP commercial production facility.
Helpful resources
We provide high-quality clinical trial materials to support your pursuit of regulatory approval, offering fit-for-purpose formulations for Phase I and Phase IIa studies and a comprehensive range of finished dosage forms for Phase IIb and Phase III studies.
We offer experience, reliability, and a broad range of commercial capabilities. We have an enviable record of helping our clients achieve oral solid dose commercialization success. Leveraging our commercial production and clinical trials solutions will give you extensive access to global technical experts, solutions, global regulatory insights, and transportation.
Getting your early development process right from the start can help save time and money as you advance through each phase and on to commercialization. We offer dedicated development hubs, engineered solutions, advanced chemistry, and innovative process technologies provided by our team of early development global experts and scientists to support your unique project. Our team understands the molecule challenges from early development to commercial and are here to help you minimize experimental efforts and reduce risk.
Gain access to an integrated drug program for flexible and tailored solutions along with a variety of early development programs that inject speed and flexibility into your small molecule’s lifecycle.
- Patheon™ Quick to Clinic™ helps reduce the time it takes to get your discovery to patients
- Quadrant 2™ predictive modeling analyzes your compound’s specific molecular structure and chemical characteristics in combination with your unique target product profile.
For pharmaceutical companies without their own facilities, choosing the right partner for late phase clinical trials and commercial production is a critical consideration for getting to market faster.
Flexibility and reliability are keys to ensuring fast delivery of your program, which is why we provide a fully integrated package of services to meet your programs specific requirements.
- Patheon™ Quick to Care™ streamlines the supply chain and accelerates development.
- Continuous manufacturing provides flexibility and cost savings.