Life Cycle Management

Life Cycle Management of Drug Products

Life Cycle Management (LCM) is a strategic approach in the pharmaceutical industry that maximizes the value of a drug product throughout its entire lifecycle—from development and market launch to maturity and eventual decline. By continuously enhancing formulations, manufacturing processes, and delivery systems, LCM ensures a product remains competitive and compliant in an evolving market landscape.

Why is Life Cycle Management Important?

Maximizing Market Value

• • Extending the patent life or exclusivity period through formulation or delivery innovations.
  • Sustaining sales and revenue growth even after patent expiry by introducing differentiated products.

Adapting to Market Needs

• • Addressing new therapeutic applications or patient demographics (e.g., pediatric or geriatric).
  • Enhancing convenience through novel dosage forms like orally disintegrating tablets or controlled-release systems.

Regulatory Compliance

• • Maintaining compliance with evolving regulatory standards, ensuring market continuity.

Cost Optimization

• • Implementing efficient manufacturing techniques to reduce production costs.

Possibilities in Oral Solid Dosage Forms for Life Cycle Management

Controlled-Release Formulations

• • Benefits: Improves patient adherence by reducing dosing frequency.
  • Example: Switching from immediate-release to extended-release tablets.

Fixed-Dose Combinations (FDCs)

• • Benefits: Combines multiple active ingredients to improve treatment efficacy and convenience.
  • Example: Hypertension or diabetes management drugs.

Orally Disintegrating Tablets (ODTs)

• • Benefits: Enhances usability for patients with swallowing difficulties.
  • Example: Reformulating for pediatric or geriatric populations.

Advanced Coating Technologies

• • Benefits: Targeted delivery (e.g., enteric coatings for delayed release).
  • Example: Gastro-resistant coatings for acid-sensitive drugs.

Modified Particle Technologies

• • Benefits: Improves bioavailability or modifies the release profile.
  • Example: Utilizing spray granulation for uniform API dispersion.

Line Extensions

• • Benefits: Addresses diverse market needs by introducing new strengths, flavors, or formulations.
  • Example: Launching chewable tablets or liquid forms.

How Glatt Pharmaceutical Services Supports Life Cycle Management

At Glatt Pharmaceutical Services, we specialize in supporting pharmaceutical companies with innovative solutions to enhance and extend the lifecycle of oral solid dosage forms. Our expertise spans formulation, process optimization, and advanced manufacturing technologies.

Key Services and Solutions

Formulation Development and Enhancement

• • Development of controlled-release and modified-release formulations.
  • Optimization for bioavailability enhancement using spray drying or hot melt extrusion.

Granulation and Coating Technologies

• • Expertise in fluidized bed technology for spray granulation, pelletization, and Wurster coating.
  • Application of advanced coatings for gastro-resistance or sustained release.

Particle Design and Engineering

• • Precise particle size control and API dispersion for uniformity and improved drug performance.

Scaling Up and Commercial Manufacturing

1. • GMP-compliant production of oral solids, ensuring high-quality and scalable solutions.
   • Efficient processes to reduce costs while maintaining quality.
2. Custom Product Development
   • Co-developing tailored solutions, including fixed-dose combinations, layered tablets, or novel drug delivery systems.

Why Partner with Glatt Pharmaceutical Services?

• Proven Expertise: Decades of experience in oral solid dosage forms.
• Innovative Technologies: Access to cutting-edge particle design and coating solutions.
• Comprehensive Support: From early-phase development to commercial-scale production.
• Customer-Centric Approach: Collaborative partnerships to achieve tailored results.

Contact Us

Let Glatt Pharmaceutical Services help you unlock the full potential of your drug products through innovative Life Cycle Management strategies.

Get in Touch to learn more about our services and solutions tailored for oral solid dosage forms!