Modified Release

Modified release formulation development and manufacturing are notoriously challenging. Recro Gainesville has the experience and organizational know-how to get your oral solid dosage product right.

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Pioneering modified release since the 1980s at one of the first U.S. sites to apply this technology, our scientists have decades of experience in the field. With an extensive history of manufacturing modified release dosage forms, our development and commercial teams are ready to leverage their keen insights and offer solutions to advance your project.

With right-sized, proactive management, a proven track record of tackling the most complex formulations, and unparalleled regulatory expertise, our specialists will collaborate with you from concept to commercialization — and at every milestone in between — to deliver a modified release formulation and process that exceed your expectations.

Commercially Manufactured Drugs That Are Modified Release

Recro Formulators With a Ph.D.

Combined Development Experience

Partner with us for modified release development and manufacturing to benefit from:

A Legacy of Experience

One of the most experienced teams in the business, Recro Gainesville has been developing modified release dosage forms for over 35 years. With 130+ years of combined development experience, you can count on us for ingenuity, perseverance, and an ethic of excellence.

Master Formulators

From high-drug-load modified release dosage forms to DEA-controlled substances to high potency compounds, no matter how challenging your project, our formulators have the skills and knowledge to efficiently develop a modified release formulation that meets your product specifications. We specialize in multiparticulates, matrix tablets, and capsules.

Company-Wide Focus On Modified Release

At Recro Gainesville, it’s not only the formulation development and analytical scientists who are skilled in modified release. From quality to regulatory to facilities and operations, the entire organization is experienced in supporting these complex products. Delivering safe and effective oral solid dosage forms is our utmost priority, and all staff is trained in and attuned to the particular considerations of modified release product development and production.

Concept to Commercialization

At Recro Gainesville, we have the diversity of capabilities to handle even your most complex development and manufacturing projects — from formulation and analytical method development all the way to manufacturing, pharmaceutical packaging, and logistics. Our scalable equipment trains support these transitions and tech transfers. Need a powder layering process for making pellets at commercial scale? How about granulation or microencapsulation? We’ve got you covered.

Culture of Collaboration

Recro Gainesville is your right-sized right partner with the right expertise. You’ll never be lost in the shuffle because our scientists honestly value collaboration: Call and talk to us and take part in your own project. Your goals are our goals, so we provide all the flexibility and specialization you could ask for to get the job done.

Unparalleled Regulatory Support

Recro Gainesville is unique in our ability to address all your regulatory needs from concept to commercialization, including CMC. From formulation development through analytical development and method validation to clinical supply manufacturing and scale-up, you’ll have access to our regulatory know-how and all the information you need to make informed decisions. You’ll have clear direction regarding everything you must do, from the beginning — and also receive expert guidance about what may not be required, given the goals of your program. Our regulatory team will even draft and submit your IND (or other regulatory submissions) for you and help you prepare so that you go into your FDA meetings with confidence.

Have a project in mind? Recro Gainesville is your go-to for modified release.

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Modified Release Resources

How to Achieve Different Release Profiles and Select Excipients for Formulation Development of Modified Release Oral Solid Dosage Forms

In pharmaceutical manufacturing, the formulation and manufacture of modified release oral solid dosage forms is highly specialized. To obtain the desired release profile(s), a holistic approach is necessary. This paper details numerous considerations for the planning and execution of a successful modified release oral solid dosage formulation.

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Is Wurster Processing the Right Choice for My Multiparticulate Modified Release Dosage Form?

Wurster processing is an extremely versatile pharmaceutical development and manufacturing technique for multiparticulates to be used in modified release (e.g., extended or controlled release) dosage forms. How do you know if it’s the right method for your modified release project?

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