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Pharmaceutical Manufacturing and Packing Sourcer

Oral Dosage Forms and Tailoring Products to the Consumer

PMPS: Patients with difficulty swallowing are an important area of your work. What things must be considered to ensure that oral disintegrating tablets (ODTs) can work without compromising on effectiveness?

Doug Hovey: Patient-centric, or patient-friendly dosage forms like ODTs, are very effective products to administer to patients who may have difficulty swallowing. These types of products actually provide more dose accuracy assurance than other dosage forms, such as oral solutions and suspensions, which can also be administered to patients with swallowability challenges. The FDA released a guidance recently questioning the effectiveness, stability, and safety of oral suspensions and solutions, stating dose accuracy as one of the issues with these dosage forms. Orally dispersible dosage forms like ODTs and chewable tablets mitigate dose accuracy issues and can provide a safe and efficacious dosage form for patients who have difficulty swallowing.

What are the top three things that require innovation in the industry to accelerate its development?

As a global leader in providing products and solutions for patient-centric dosage forms, manufacturers need only to add their active pharmaceutical ingredient (API), and any ancillary ingredients if needed (i.e., flavours, sweeteners, lubricant) to these drug delivery technologies to create their final dosage form. Requirements for new innovations should be beneficial for both the manufacturers and the patients. For the manufacturer, this would include products that can help accelerate their development, as well as help with challenging formulations and active ingredients. For the patients, ease of use and consistent performance will continue to be important, but more innovation is needed to create products and technologies designed to help improve bioavailability, lessen side effects, and provide a faster onset of action.

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Doug Hovey is currently the Technical Development Manager in North America for SPI Pharma. He has been in the pharmaceutical industry for nearly 25 years with a proven track record highlighted by his direct involvement in six approved drug products. He has a diverse background with a strong knowledge in pharmaceutical sciences and understanding of the requirements needed for a successful regulatory filing and efficient manufacturing process. Doug has a broad base of experience in the areas of formulation development and technical service. He worked as a product development scientist for over 15 years before moving into a technical service and business development role within the pharmaceutical excipient industry.
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