Formulation Development

Conscio provides comprehensive formulation development services, from early feasibility and proof-of-concept studies to advanced formulation design, process optimisation, and upscaling for clinical supply. We support a broad range of projects, including new chemical entities (NCE), new therapeutic entities (NTE), generics (Gx), and over-the-counter (OTC) products.

Formulation Development

Approach to Your Project:

Project initiation – Definition of project goals and target product profile (TPP) in close collaboration with the client
Strategy and IP review – Identification of potential development risks, assessment of intellectual property considerations, and recommendation of suitable technologies
Proof-of-concept – Evaluation of specific needs, including high-potency APIs, narcotics, and special processing requirements (e.g., isolator technology)
Innovative solutions – Development of tailored feasibility strategies to address formulation challenges
Formulation planning – Creation of customised development strategies aligned with the defined TPP
Upscaling and production – Transition from laboratory trials through process optimisation to IMP manufacturing in GMP facilities

Capabilities:

Project Feasibility & Target Product Profile Definition
IP checks and strategic technology recommendations
Advanced development phases including DoE and process validation
Analytical method development and validation
Stability studies according to ICH guidelines
Release testing of starting materials and drug products
IVRT/IVPT testing (EMA/FDA guidelines)
Technical transfer from and to GMP facilities

Solutions for Drug Delivery:

Formulation expertise at Conscio spans a wide range of drug delivery challenges — from improving solubility and bioavailability to developing complex dosage forms and value-added formulations. By applying advanced technologies each product can be designed to meet its intended performance, stability, and regulatory requirements.

Solubility & Bioavailability:
- Solubility enhancement (e.g., hot melt extrusion, spray drying, fluid bed)
- Micro/nano delivery systems
- Fast-acting orodispersible films
- Ionic liquids

Hard-to-Make Forms:
- Abuse-deterrent/narcotic formulations
- High-potency APIs
- Multi-dose and modified-release products
- Transdermal systems

Lifecycle & Value-Added:
- Patent circumvention
- Early market access
- Taste masking/targeting
- Innovative delivery (e.g., hydrogels)

Dosage forms:

Capabilities include the development of a broad spectrum of dosage forms, covering solid, liquid, semi-solid, and specialised delivery systems. Each form is designed with consideration for patient needs, therapeutic goals, manufacturing feasibility, and regulatory compliance.

Solid Dosage Forms: Mono- & bi-layer tablets, including super-fast dissolving/modified-release, Capsules, mini-tablets, multi-particulates, direct granules, filaments, and pellets
Liquid & Semi-Solid Forms: Ointments, creams, gels, foams, suspensions, Liquids, inks
Special Dosage Forms: Oral thin films, Transdermal patches (TTS), innovative peptide dosage forms, E-health dosage forms (e.g., patch pump, e-patch)