ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• The Role Of The Contract Manufacturer In Medical Device Development

  With a trusted contract manufacturing partner, pharma companies can ensure that their innovative therapies come to market efficiently without compromising the quality of the drug and its delivery system.

• Seven Softgel Myths: Are You Missing Your Softgel Opportunity?

  Softgels are a popular dose format among consumers, thanks to their high swallowability and quick onset of action, yet pharmaceutical developers may not even consider them. Why the disconnect?

• From Regulators To PUPSIT: Notes On Annex 1 Revision Implementation

  Kevin Smyth, a biochemical engineer with 30 years of experience in the pharmaceutical industry, offers insights and expertise in working with firms to understand what regulators seek to meet new standards.

• Stopper Functionality – Key Considerations

  When selecting the appropriate rubber stopper for any respective vial containment system, there are many aspects to consider regarding the properties of the elastomeric closure.

• Autoinjectors: A Revolutionary Leap In Drug Delivery

  Explore how the widespread adoption of autoinjectors is transforming the biopharmaceutical industry's approach to drug delivery, offering precise dosing, patient adherence, and safety.

• White Paper: Nasal Delivery Of Spray Dried Biologics: Opportunities And Challenges

  Explore the potential of spray-dried nasal formulations for biologics to achieve excellent stability and targeted delivery, paving the way for innovative and effective therapeutic solutions.

• Design Verification Testing Of Combination Products

  Developing a combination product and seeking a list of tests to complete design verification testing? Review the details for planning, design inputs, design outputs, and design verification.

• Rational Design Of Oral Nanosuspensions For Insoluble Drugs

  The advantages of nanosuspension dosage forms include improving bioavailability and API stability, increasing drug loading, better dose flexibility and accuracy, and easy swallowing for pediatric or geriatric populations.

• Decoding the FDA Guidance on Essential Drug Delivery Outputs

  The FDA’s draft guidance Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products discusses general concepts around essential drug delivery outputs (EDDOs). The guidance’s potential impact spans several device development topics, including design outputs, verification/validation, and control strategy.

• Unlocking A Patient Preference For Rapid Onset In Treating Migraines

  Examine the case study and learn how formulating an orally disintegrating tablet (ODT) created a convenient dosage form with a shorter T_max for the treatment of acute migraine.