Quality Standards in Oral Drug Development

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

ORAL DOSAGE DEVELOPMENT EXPERTISE AND CAPABILITIES

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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.

Our Core Offerings:

  • Highly Potent Compounds (including Safebridge Category IV and Hormones)
  • DEA Controlled Substances (Schedule I-V, L1)
  • Combination of Multiple APIs
  • Pre-formulation to Phase III Studies
  • Bioavailability enhancement
  • Modified-and controlled-release tablets, capsules, and suspensions
  • Formulation of complex drug products
    • Multi-particulate 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)

From Concept to Clinic in 100 Days

Speed to market matters. Our team of experienced scientists will take your drug or blend in capsule / powder for reconstitution into a bottle within 14 weeks with 1 M stability.
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OUR CORE OFFERINGS IN ORAL SOLID DOSAGE DRUG DEVELOPMENT AND DELIVERY

Particle Engineering

Our scientists and engineers utilize our specialized equipment to obtain the optimal particle size and size distribution as well as other aspects and surface characteristics to improve solubility and bioavailability for your drug. Our team has a thorough understanding of which approach is needed for each specific API type, avoiding costly trial and error.

Particle size reduction capabilities include:

  • Spray-dried dispersion
  • Nanoparticles via wet milling
  • Drug Layering and Particle Coating (Wurster and Top Spray)
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Solubility and Bioavailability Enhancement

Each drug formulation is unique. Without the right solutions, poor solubility issues, inadequate bioavailability and/or unacceptable physical or chemical stabilities can severely complicate drug delivery. While 90% of the drugs in development are poorly soluble, there are highly successful methods our team will employ.

Techniques to enhance solubility and improve bioavailability include:

  • Solubilization with GRAS solvents for the desired drug load
  • Lipid-based systems / Self-micro emulsifying drug delivery system (SMEDDS)
  • Spray-dried dispersion
  • Nano-suspension
  • Inclusion Complexes

Programmed Drug Release

We have the technology to provide precise control over the drug release at the desired absorption site and the quantity of a drug introduced into the body to reduce side effects, improve patient outcomes and maximize the effect of the drug.

Our programmed drug release techniques:

  • Immediate release / Orally disintegrating
  • Delayed release / Enteric release
  • Extended release
  • Controlled release (including Zero-order)
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Downstream Manufacturing

Various technologies used at Pii to improve solubility and bioavailability and programmed drug release are supported and delivered into appropriate dosage form utilizing various downstream manufacturing processes.

Downstream manufacturing options include:

  • Tablets (including multi-layer, tablet-in-tablet, minitablets, laser drilled, MUPS)
  • Capsules (hard shell, liquid-filled hard shell LFHS, soft gel)
  • Solution, Suspension, Powder for Reconstitution
  • Coating (tablet, capsule, powder, pellets)

SOLID DOSE DELIVERY FORMS

Tablet

Traditional Tablets

Powder Forumulation

Powders

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Coated Tablets

Capsule Forumulation

Capsules

We’re Ready to Get Started

Our proven and experienced formulation scientists are ready to discuss your unique Oral Solid Dose needs. We will be invaluable in the early stage of development so that we can quickly take you from concept to clinic to commercialization.

Contact a Pii Ambassador for your next oral dose project