Rush Now and Regret Later or the Importance of Getting the Formulation Strategy Right from the Start

Formulation design

How to choose the right CDMO from the start ?

In the pharmaceutical industry, the road from an idea to a safe, effective, marketable solid oral dosage form can be full of technical challenges. Poor formulation choices early on often surface later as stability failures, scale‑up issues, solubility and bioavailability problems, regulatory setbacks, and costly reformulations, all of which lead to delays and unexpected costs.

That’s why selecting a CDMO with deep formulation expertise in solid oral dosage forms is not just beneficial, it’s essential to protect your time-to-market, budget, and product quality.

More concretely, the right CDMO partner:

  • prevent technical issues before they happen
  • reduce development cycle
  • limit trial-and-error
  • help you avoid costly reformulation
  • increase chances of successful scale-up on the first attempt

 

Put simply, the right CDMO partner is a long-term guarantee of your project’s success.

Formulation expertise of your CDMO partner can reduce the risks from day one

Working with a CDMO that lacks deep formulation expertise often looks cheaper — until formulation issues surface months or even years later, triggering:

❌ stability failures
❌ delayed filings
❌ costly reformulations
❌ manufacturing bottlenecks
❌ supply interruptions

Starting a development project according to the Quality by Design (QbD) approach is all about planning, understanding, and designing quality into the product from day one, rather than trying to “test quality in” at the end.

Why Skyepharma is the right choice for complex pharmaceutical development projects ?

At Styepharma, we build robust formulations from the start grounded in Quality by Design (QbD) principles, analytical insight, and process understanding. By applying QbD, Skyepharma ensures that formulations are robust, scalable, and predictable, reducing the risk of delays, unexpected failures, or costly reformulations. The approach also allows for better understanding of the product and process, enabling faster decision-making, more efficient scale-up, and consistent performance in commercial manufacturing.

In addition, we constantly invest in innovation. So we don’t just use established technologies, we opting for advanced technologies for oral delivery. Our innovation programs, developed with top universities, tackle key industry challenges such as:

✅ enhancing bioavailability for poorly soluble APIs (Nanomics and Nanofact programs)

✅ developing targeted delivery strategies across the GI tract (MucoTabS and GeoColon programs)

✅ exploring oral delivery for biologics traditionally limited to injections.

These programs feed directly into Skyepharma’s capabilities, offering partners access to next‑generation solutions and potential IP advantages that go far beyond standard CDMO services.

We also have our own proprietary controlled release platforms such as:

  • Geomatrix® : controlled release tablet system enabling customized multi‑layer release profiles.

  • Geoclock® :a press‑coated technology enabling timed and targeted release, including colonic delivery.

  • Soctec® : a gastro‑retentive capsule system designed to increase residence time and improve API absorption.

These technologies deliver patient‑centric benefits (better efficacy, fewer side effects) while giving partners enhanced control over product performance and market differentiation.

Still looking for your future oral solid dosage form development partner CDMO? Our team will be delighted to answer your inquiries.

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