Services / Oral Drugs

Oral Solid Dosage Forms

From first prototype to GMP clinical supply. We know oral solid.

Tablets and Capsules Immediate Release Formulations Modified Release Formulations Multiparticulates Coating and Particle Engineering
Committed. Reliable.

The most trusted dosage form in medicine. We develop it with the precision it demands.

We are experts in oral solid dosage forms — the most prescribed format in medicine, and one of the most technically demanding to get right.

Tablets and capsules offer unmatched convenience, excellent physical and chemical stability, precise dosing, and a well-understood regulatory pathway. For most small molecule programmes, an oral solid dosage form is not just a preference. It is the strategic goal.

But developing a robust, scalable oral solid dosage form is rarely straightforward. From selecting the right formulation strategy and excipient system, to designing processes that perform consistently from lab scale to GMP manufacturing, to engineering release profiles that match the pharmacokinetic requirements of the indication. The decisions made early in development have long-reaching consequences.

We develop and manufacture a broad range of oral solid dosage forms, from simple immediate-release tablets to advanced modified-release systems and multiparticulates, across the full development continuum. Our formulation scientists, process engineers, and analytical chemists work as one integrated team, ensuring every formulation decision is made with clinical performance, manufacturing robustness, and regulatory success in mind.

WHAT WE OFFER

01 Tablets and Capsules

Conventional and Advanced — Coated, Uncoated, and Everything Between

We develop and manufacture a wide range of tablet and capsule formats:

  • Uncoated tablets — direct compression and wet or dry granulation routes, optimised for the physical properties of the API and excipient blend
  • Film-coated tablets — functional and non-functional coatings for appearance, stability, taste masking, and moisture protection
  • Hard capsules — powder-filled, pellet-filled, and multiparticulate formats in gelatin and HPMC shells
  • Modified-release tablets and capsules — matrix systems, membrane-coated systems, and enteric formulations designed to control drug release rate and location in the GI tract

Formulation strategy selection is driven by the API’s physicochemical profile, the target release specification, dose, and the practical requirements of GMP manufacturing — not by default preference.

02 Immediate-Release Formulations

Fast Onset. Straightforward Development. Efficient Path to Clinic.

Immediate-release formulations are designed to release the drug rapidly after administration, achieving fast onset of action and predictable pharmacokinetics. For many programmes, particularly in early clinical development, a well-designed immediate-release tablet or capsule is the most efficient and risk-appropriate formulation strategy.

We develop immediate-release formulations using a phase-appropriate approach — applying the level of formulation complexity, analytical rigour, and process development effort that the stage of development demands. This keeps early-phase programmes moving efficiently while building the formulation understanding needed to support later-phase manufacturing and regulatory submissions..

03 Modified-Release Formulations

Controlled Release Profiles. Reduced Dosing Frequency. Improved Patient Experience.

Modified-release formulations extend or modulate drug release beyond what immediate-release systems can achieve — enabling sustained plasma concentrations, reduced peak-to-trough fluctuations, lower dosing frequency, and in some cases improved tolerability. For compounds with short half-lives, narrow therapeutic windows, or GI tolerability challenges, a modified-release strategy can be clinically transformative.

Our modified-release capabilities cover the principal technology platforms:

  • Matrix systems — hydrophilic, hydrophobic, and lipid-based erosion and diffusion matrices for sustained-release profiles
  • Membrane-coated systems — rate-controlling polymer coatings on tablets or pellets for precise dissolution profile design
  • Enteric systems — delayed-release coatings that protect acid-sensitive APIs or target drug release to the small intestine

Release profile design is supported by in vitro dissolution modelling and, where needed, IVIVC development — linking in vitro performance to in vivo pharmacokinetic expectations.

04 Multiparticulates

Flexible Release Engineering. Reduced Clinical Risk.

Multiparticulate systems — pellets, beads, and coated particles filled into capsules or compressed into tablets — offer a level of release engineering flexibility and clinical risk management that monolithic dosage forms cannot match.

Because the dose is distributed across thousands of discrete particles rather than a single unit, multiparticulates offer several practical advantages:

  • Reduced dose-dumping risk — no single failure mode can release the entire dose at once
  • Blended release profiles — immediate- and modified-release populations can be combined in a single capsule, delivering a biphasic or complex PK profile from one dosage unit
  • Fine-tuned dissolution control — functional coatings applied to individual particles allow precise, reproducible modulation of drug release rate and trigger point

We develop pellet and bead systems using extrusion-spheronisation and bead-layering techniques, with functional coating applied in fluid bed equipment. These approaches are suited to both small-molecule APIs and compounds where the multiparticulate format is used downstream of an enabling technology intermediate — such as a nanosuspension or amorphous solid dispersion.

05 Coating and Particle Engineering

Every Layer, Designed with Purpose

Coating is not a finishing step — it is a formulation tool. Whether the objective is taste masking, moisture protection, API stability, modified release, or enteric targeting, the coating system must be designed and characterised with the same rigour as the core formulation.

Our coating capabilities include:

  • Film coating — aqueous and solvent-based systems for non-functional tablet and capsule coating
  • Functional modified-release coatings — rate-controlling polymer systems (ethylcellulose, Eudragit grades, HPMC-AS) for sustained and enteric release
  • Taste masking coatings — applied to granules, pellets, or mini-tablets for patient-friendly oral dosage forms, including paediatric applications
  • Protective coatings — moisture and light barrier systems for stability-sensitive APIs

Coating process development includes optimisation of spray rate, inlet temperature, atomisation, and pan speed to deliver uniform, defect-free coatings at both development and GMP scale.

INTEGRATED DEVELOPMENT AND GMP MANUFACTURING

One Team Across Formulation, Analytics, and Manufacturing

The most common source of delay in oral solid dosage development is the handoff — between formulation and analytical teams, between development and manufacturing, between one organisation and the next. Each transition is an opportunity for specification gaps, communication failures, and lost process understanding.

Our oral solid dosage development is fully integrated. Formulation scientists, analytical chemists, and process engineers work as a single team from the first formulation experiment through to GMP batch release. Analytical methods are developed alongside the formulation. Manufacturing processes are designed for the equipment at the clinical manufacturing scale, not just the laboratory. Release specifications are agreed with the full manufacturing context in mind.

This integrated approach delivers:

Formulation development and screening

excipient selection, formulation optimisation, and prototype manufacturing with phase-appropriate complexity

Process development and scale-up

granulation, blending, compression, encapsulation, and coating processes characterised and scaled for GMP manufacturing

Analytical method development and release testing

dissolution, assay, content uniformity, related substances, and stability methods developed and validated in-house

GMP clinical batch manufacturing

Phase I through Phase III supply at Ardena's GMP-certified manufacturing sites

Why clients come to us for oral solid.

Formulation Science and Manufacturing Capability, Fully Aligned

  • Broad dosage form range — immediate-release, modified-release, enteric, and multiparticulate systems across tablets, capsules, and advanced formats
  • Enabling technology integration — oral solid dosage development connected directly to our HME, spray drying, nanosuspension, and lipid formulation platforms.
  • Phase-appropriate development — formulation and process complexity scaled to the development stage, keeping early-phase programmes efficient without compromising the foundation for later-phase manufacturing
  • Single-site integration — formulation, analytical, and GMP manufacturing under one roof at multiple sites
  • Regulatory-ready CMC documentation — process development reports, analytical method validation, stability data, and manufacturing batch records prepared to support IND, CTA, and NDA/MAA submissions

Small Molecule Development

End-to-end development for small molecules with complex profiles — poorly soluble compounds, highly potent APIs, controlled substances, and challenging physicochemical characteristics. Our scientists know where the problems hide and how to get ahead of them. From first formulation to GMP batch, your program stays in expert hands.

Discuss Your Program
Key Capabilities
Process Chemistry & Scale-Up
Polymorph & Salt Screening
Oral & Injectable Formulations
Analytical Method Development
GMP Manufacturing
Clinical Trial Supplies
Insights

Related Resources

Our expert team members share deep, scientific understanding and insights into oral drug development and manufacturing.

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CONTACT US

Direct contact

contact@ardena.com