Quality Standards in Oral Drug Development

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

ORAL DOSAGE DEVELOPMENT EXPERTISE AND CAPABILITIES

Oral Dosage Development

Oral Dosage Development

Our range of innovative oral dose delivery formulation options gives your drug the best chance for improved solubility, bioavailability, and stability while delivering the right dose at the right time for the patient. Pii’s proven and experienced formulation scientists will be invaluable in the early stages of development to ensure your dosage form meets the target product profile (TPP) by providing a forward-thinking approach to anticipate and eliminate potential future challenges or delays.

Our Core Offerings and Capabilities:

  • Pre-formulation to Clinical to Commercial
  • Handling Highly Potent Compounds (including Safebridge Category IV and Hormones)
  • Licensed for DEA-Controlled Substances (Schedule I-V, L1)
  • Multiple API Combination Products
  • Bioavailability Enhancement
  • Modified-, Targeted-, and Controlled-Release Tablets and Capsules
  • Soft Gels, Oral, Liquids, and Suspensions
  • Formulation of Complex Drug Products
  • Multi-particulates/solvent and aqueous based granulations
  • Spray Dried Dispersions (SDD)
  • Particle Engineering (e.g. nanoparticles, drug layering, coated particles)
  • Solubility Enhancement (e.g. SEDDS, SMEDDS, lipid-based systems, SDD, nanoparticles)

SOLID DOSE DELIVERY FORMS

Tablet

Traditional Tablets

coated tablets blue forumulation

Coated Tablets

Capsule Forumulation

Capsules

From Concept to Clinic in 100 Days

Saving time and money in the early stages of development is important.  Our experienced team of scientists takes an innovative approach to drug delivery within 14 weeks, including 1 month stability -- because speed to market matters.

OUR CORE OFFERINGS IN ORAL SOLID DOSAGE DRUG DEVELOPMENT AND DELIVERY

Particle Engineering

Our scientists utilize our specialized equipment to obtain the optimal particle size and size distribution, as well as other aspects such as surface characteristics to improve solubility and bioavailability for your drug. The skilled Pii 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)
Particle Engineering
Solubility Bioavailability Enhancement

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
  • Nanosuspension
  • Inclusion Complexes

Programmed Drug Release

We have the technology to provide precise control for drug release at the desired absorption site, as well as the quantity of  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 tablets
  • Delayed and Enteric Release
  • Targeted Release
  • Extended Release
  • Zero-Order Controlled Release
Programmed Drug Release
Downstream Manufacturing

Downstream Manufacturing

Various technologies used at Pii to improve solubility and bioavailability and programmed drug release are supported for scale-up and tech transfer using various downstream manufacturing processes.

Downstream manufacturing options include:

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

We’re Ready to Get Started

Our proven and experienced formulation scientists are ready to discuss your unique Oral Dose needs. The Pii team will take you quickly from concept to clinic to commercialization, saving time and money while delivering your product to those patients in need.

Contact a Pii Ambassador for your next oral dose project