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Formulation Research & Development

Comprehensive Formulation Capabilities

Dosage Form Development

Globesynth Pharma Tech offers extensive experience across a broad spectrum of dosage forms, tailored to both innovator and generic pharmaceutical programs:

Oral Solid Dosage Forms

Immediate-release (IR), modified-release (MR), sustained-release (SR), and delayed-release (DR) tablets
Film-coated, enteric-coated, and multilayer tablets
Hard gelatin and HPMC capsules
Multiparticulate systems (pellets, granules, MUPS)

Liquid Dosage Forms:

Oral solutions, suspensions, emulsions, and syrups
Pediatric and geriatric-friendly formulations
Preservative and solvent optimization for safety and stability

Semi-Solid Dosage Forms:

Topical creams, ointments, gels, and lotions
Dermatological and transdermal applications

Parenteral & Sterile Products:

Injectable formulations (aqueous and non-aqueous)
Lyophilized (freeze-dried) products
Sterile filtration and aseptic process compatibility studies

Specialized Dosage Forms:

Sublingual and buccal formulations
Orally disintegrating tablets (ODTs) and films (ODFs)
Fixed-dose combinations (FDCs)

Advanced Drug Delivery & Enabling Technologies

We apply innovative drug delivery approaches to overcome formulation challenges and enhance therapeutic performance:

Controlled and modified-release technologies
Bioavailability enhancement for poorly soluble and BCS Class II/IV drugs
Particle size reduction and nano-formulation strategies
Lipid-based and solubility-enhancing systems
Taste masking technologies to improve patient compliance
Excipient selection aligned with regulatory acceptability

Pre-Formulation & Analytical Development Support

A strong analytical foundation ensures scientifically robust and regulator-ready formulation development:

Pre-Formulation Studies

API physicochemical characterization
Solubility and pH profiling
Solid-state characterization and polymorphism studies
Particle size distribution and flow property evaluation
Hygroscopicity and thermal behavior studies

Analytical Development

Development of stability-indicating analytical methods
Method validation as per ICH guidelines
Dissolution method development and optimization
Impurity profiling and degradation pathway evaluation
Support for extractables and leachables assessments (as applicable)

Formulation Design & Optimization

Prototype Development

Rational formulation design using Quality by Design (QbD)
Application of Design of Experiments (DoE) for formulation optimization
Excipient screening and risk assessment
Rapid development of clinical trial and pilot formulations

Process Optimization

Selection of suitable manufacturing processes:

Direct compression
Wet and dry granulation
Roller compaction
Coating technologies

Identification and control of Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs)

Scale-Up, Technology Transfer & Manufacturing Readiness

Laboratory-to-pilot-scale development
Pilot-scale batch manufacturing support
Technology transfer packages for commercial manufacturing
Process validation support and continued process verification
Coordination with third-party GMP-compliant manufacturing facilities

Stability & Lifecycle Management

ICH-compliant stability studies (accelerated, intermediate, long-term)
Photostability and stress studies
Shelf-life estimation and storage condition recommendations
Support for post-approval changes and lifecycle management

Bioavailability & Bioequivalence Support

Formulation optimization for enhanced in-vivo performance
Comparative dissolution and similarity factor (f2) studies
Support for BA/BE studies for generic development
IVIVC support where applicable

Regulatory Strategy & Documentation

Globesynth Pharma Tech ensures that all formulation programs are regulatory-ready and aligned with global submission standards:

Preparation of CTD Modules 2 & 3
ANDA, NDA, and lifecycle management submissions
Compliance with ICH, US FDA, EMA, MHRA, and other global agencies
Regulatory responses and deficiency support

Client-Focused Engagement Models

Flexible engagement models (project-based or dedicated teams)
Confidentiality and IP protection
Transparent communication and milestone-driven execution
Customized solutions aligned with client timelines and budgets

Why Globesynth Pharma Tech for Formulation R&D?

Integrated formulation, analytical, and regulatory expertise
Proven experience with complex APIs and challenging formulations
Strong quality systems and compliance culture
Scalable solutions from early development to commercialization
Reliable, confidential, and science-driven partner