Dosage Form and Drug Delivery Know-How™

Our experienced and proven team of scientists, engineers and regulatory professionals, will deliver your molecule or biologic in the optimal drug formulation while ensuring the highest-quality standards in drug development and drug delivery systems utilizing QbD principles for oral and parenteral dose forms.

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IMPROVE AND ACCELERATE YOUR DRUG
FROM CONCEPT TO CLINIC TO COMMERCIAL SUPPLY

Injectable Drugs and Biologics

Pii enables biotech and pharmaceutical companies to dramatically accelerate timelines with our proven capabilities in aseptic filling, terminal sterilization and lyophilization of biologic NCE, small molecule, potent up (HPAPI) to SafeBridge® Category 4 and cytotoxic drugs into vials, syringes and cartridges. Our focus is on accelerating decision-making at every step of the drug development process utilizing QbD to meet your project milestones, while also providing rapid access to manufacturing slots and quick release of drug product for clinical trial or commercial supply. All parenteral products are processed and tested in strict accordance with cGMP requirements. Our services include:

  • Sterile dosage forms
  • Lyophilized products
  • Suspensions and highly viscous liquids
  • Long-acting and depot injectables
  • Vials, syringes and cartridges
  • Drug device combination products

Learn more about Lyophilization Cycle Development Services

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DELIVERING THE RIGHT DOSAGE AT THE RIGHT TIME

Oral Dosage Development

Our range of oral dose delivery options gives your drug excellent solubility and stability, delivering the right dosage at the right time in the patient’s body. This is where Pii’s proven and experienced formulation scientists will be invaluable in the early stages of development to ensure meeting the target product profile (TPP) by providing a forward-thinking approach to anticipate and eliminate potential future challenges.

  • Pre-formulation to Phase III Studies
  • Bioavailability enhancement
  • Highly potent (SafeBridge® Category 4) and hormone-containing products
  • DEA schedule I-V (Controlled Substances)
  • Products with multiple APIs (e.g. combination products)
  • Modified and controlled-release tablets, capsules and suspensions
  • Formulation of complex drug products
    • Multilayer tablets
    • Multiparticulate tablets and capsules
    • Spray drying dispersions (SDD)
    • Particle engineering (e.g. nanoparticles, drug layering, coated particles)
    • Solubility enhancement (e.g. SMEDDS, lipid-based systems, SDD, nanoparticles)
  • Zero-order controlled-release tablets (e.g. laser drilling)

View Our Soft Gel Capabilities

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SOLID ORAL DOSE FORMULATION CAPABILITIES

  • SoftGel and LFHS (liquid-filled hard shell)
  • Spray Dry Dispersions (SDD)
  • Controlled-Release
  • Enteric-Release
  • Extended-Release
  • Delayed-Release
  • Particle Engineering

View our Equipment List

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SOLID DOSE DELIVERY FORMS

Traditional Tablets

Bilayer Tablets

Coated Tablets

Powders

Soft Gels

Capsules

PARENTERAL DOSAGE FORMS

Vials

Suspensions

Syringes

Lyophilized Products

Talk to a Pii Scientist