Oral solid dosage forms are the most common dosage forms and the preferred option for many pharmaceutical products. They are non-invasive, convenient and typically less expensive forms of medication that patients can self-administer. In this Q&A we speak with Sanjay Konagurthu — senior director, PDS Global Science and Technologies, Pharma Services, Patheon, part of Thermo Fisher Scientific — about this sector.
Q&A
Q. What are the benefits of oral solid dosage forms over other delivery routes?
Oral solid dosage (OSD) forms are manufactured using conventional manufacturing processes such as direct blending or granulation techniques. They are the preferred delivery type for pharmaceuticals, and offer several advantages including increased chemical and physical stability through the use of tablets or capsules, unique shapes and colours that can be easily associated with a brand, and controlled-release options.Additionally, their cost-effective nature often makes them the preferred dosage form for clients. The popularity of OSD forms drives pharmaceutical formulation scientists and engineers to continually refine and improve their manufacturing processes.
Q. What challenges are you faced with when developing an OSD formulation?
Drug formulators need to be aware of a compound’s performance, stability and manufacturability throughout formulation and process development at all stages of product development. While development scientists commonly work on formulation and stability aspects in the early phases of a drug product, scale-up is not always easy. Therefore, it is necessary to develop the process knowledge at different scales of manufacturing. This knowledge should guide equipment selection, link the critical process parameters (CPPs) to critical quality attributes (CQAs) and establish the design space (DS).
Sound scientific/engineering principles and mechanistic models should be employed whenever possible for scale-up of pharmaceutical unit operations. In addition, a robust risk assessment programme invoking Quality by Design (QbD) principles at each stage of development is critical for successful scale-up.
Q. Are there specific patient groups that may benefit from OSD forms?
OSD forms are the preferred route of drug delivery due to broad patient acceptability. Strides are being made to formulate oral solid dosage products that are paediatric and geriatric-friendly by developing them such that they are easily swallowed and taste-masked, both of which lead to better patient compliance.Furthermore, as oral delivery of biologics becomes more feasible, this will open up more avenues for drugs that can currently only be administered via an injectable route.
Q. What opportunities do you foresee in the sector for the near future?
Innovation in drug delivery technologies for oral solid dosage forms is expected in the future, with improvements in safety, quality and manufacturing costs. Targeted therapies and personalised medicine arising from innovations in computer technologies, imaging and sensors is expected to result in significantly enhanced patient treatment and monitoring.
Patheon has a flexible business model to adapt to the changing demands of the industry. From a technology standpoint, as well as an integrated model for supporting client needs, there are many areas for growth within the market. For example nearly 90% of pharmaceutical industry pipelines are poorly water soluble (Biopharmaceutical Classification System Class II or IV) Patheon’s Quadrant 2 in-silico platform is a differentiated approach to solubility enhancement. This approach leverages in-depth knowledge of a molecule’s physico-chemical properties to select the appropriate solubility enhancement technology as well as guiding excipient selection thereby leading to a reduction or elimination in rework and improvement in advancement to the clinic.
Having an integrated CDMO for manufacturing of the active pharmaceutical ingredient (API) to the finished drug product and subsequent clinical packaging and distribution can result in a vastly simplified supply chain and reduces time to key milestones. This can result in significant time and cost savings by using a global network of fully integrated facilities that offer a comprehensive range of technologies and services. Patheon OneSource is designed to deliver the above strategy.
Continuous manufacturing holds great promise for the pharmaceutical industry, enabling faster pharmaceutical production and more reliable products using an uninterrupted process. The efficiencies of scale and manufacturing times compared to traditional batch processing can be significant. Continuous manufacturing is widespread in other process industries (e.g., chemical, food, automotive etc.) and significantly improves reliability, while reducing waste and costs compared with the batch method.
Q. And, what about potential pitfalls?
Development of an OSD form is a complex endeavour and has opportunities for continuous improvement and innovation. We are making great progress to deliver the most challenging molecules orally along with improvements to the supply chain and manufacturing with the assurance of product quality.
