Extending a product’s lifecycle and reaching new patient populations are key goals for any pharmaceutical company. However, when a successful drug is only available in a solid-dose form, significant barriers can arise, particularly for pediatric and geriatric patients who have difficulty swallowing pills. This case study explores how a strategic reformulation project transformed a challenging solid-dose API into a stable, palatable, and commercially successful oral syrup.
The Challenge: Overcoming Patient Adherence Barriers
Our client, a mid-sized pharmaceutical company, had a highly effective drug on the market. While commercially successful with the general adult population, they faced a significant challenge: the product’s solid-dose form was unsuitable for key growth segments, leading to issues with patient adherence and limiting market penetration.
| Project Aspect | Detail |
|---|---|
| Client | Mid-Sized Pharmaceutical Firm |
| Drug Type | Solid-Dose (Tablet) |
| Challenge | Poor patient adherence in pediatric/geriatric groups; extremely bitter API with low solubility. |
| Key Result | Successful development of a stable, palatable oral syrup, leading to pediatric market approval. |
Client’s Business Objectives
The client approached us with a clear set of commercial goals tied to this reformulation challenge:
- Primary Goal: To successfully enter the lucrative pediatric market by creating a child-friendly liquid formulation.
- Secondary Goal: To improve overall patient compliance and preference across all age groups, especially among the elderly.
- Tertiary Goal: To extend the product’s lifecycle and create a new revenue stream with a differentiated dosage form.
Key Technical Hurdles to Overcome
The project presented several significant scientific challenges that required deep expertise in oral liquid development:
- Extreme Bitterness: The Active Pharmaceutical Ingredient (API) was known to be intensely bitter, making palatability a primary obstacle for a liquid formulation, especially one intended for children.
- Poor Solubility: The drug exhibited poor solubility in simple aqueous solutions, risking inconsistent dosing and an unstable final product. A sophisticated solvent system was required.
- Long-Term Stability: The client required a commercial product with a minimum 24-month shelf life, demanding a robust formulation that could resist degradation and maintain potency over time.
The Solution: A Phased Approach to Liquid Formulation
Our team implemented a systematic, science-led reformulation process designed to mitigate risks and ensure a successful outcome. By breaking the project into distinct phases, we maintained clear communication with the client and built a comprehensive data package for regulatory submission.
Step 1: Pre-Formulation and Excipient Screening
The foundation of any successful formulation is a deep understanding of the API. We began with a full API characterization to map its physical and chemical properties. This data informed our screening of multiple solubility enhancers and stabilizing agents to find the optimal combination. We selected a panel of excipients from the FDA’s Generally Recognized as Safe (GRAS) list to ensure a clear and efficient regulatory pathway.
Step 2: Taste-Masking and Final Formulation Development
With a stable base formulation established, we focused on the critical challenge of palatability. Our team utilized advanced flavor development techniques, working with specialized flavor houses to identify masking agents that could effectively neutralize the API’s bitterness without interacting with the drug itself. We meticulously optimized the syrup’s viscosity and texture for patient acceptance. Finally, a robust preservative system was developed and tested to ensure microbial safety throughout the product’s shelf life.
Step 3: Analytical Validation and Stability Testing
To support the new dosage form, our analytical team developed and validated new, specific methods to accurately measure the API’s potency and purity within the liquid matrix. We then initiated ICH-compliant stability studies, placing the final formulation under both accelerated and real-time conditions. This generated the comprehensive data package required to prove the product’s safety, efficacy, and stability for the client’s regulatory submission.
The Results: A Successful Market Launch and Business Growth
Through our collaborative and phased approach, the project was completed on time and within the client’s budget. The final product was a highly palatable, stable, and effective oral syrup that successfully met all target product profile criteria. The results were not just technical but had a significant commercial impact.
Quantifiable Project Outcomes
- Achieved a 95% palatability score in a target pediatric patient panel, demonstrating high user acceptance.
- Confirmed 24-month shelf stability under real-time storage conditions, meeting all commercial requirements.
- Successfully scaled up the formulation from lab bench to a GMP-compliant commercial batch, ensuring a seamless transition to manufacturing.
Impact on the Client’s Business
The successful reformulation directly translated into achieving the client’s strategic goals. They gained regulatory approval for the new pediatric indication, allowing them to enter a previously inaccessible market. Within the first year of launch, the new oral syrup captured a significant share of the pediatric market, creating a powerful new revenue stream and solidifying the product’s brand loyalty across a wider patient base. Ready to achieve similar results? Plan your reformulation project with us.
Frequently Asked Questions
What is the typical timeline for a reformulation project like this?
While every project is unique, a reformulation from solid to liquid dosage form typically takes 12 to 18 months, including formulation development, stability studies, and preparation of the CMC data package for regulatory submission.
How do you handle highly sensitive or complex APIs?
Our labs are equipped to handle a wide range of complex APIs, including those sensitive to light, oxygen, or pH. We employ a science-driven approach, beginning with in-depth characterization to understand the API’s vulnerabilities and designing the formulation and manufacturing process to protect its integrity.
What is involved in the ‘tech transfer’ process for manufacturing?
Tech transfer is the formal process of transferring the knowledge and processes for manufacturing the product from our development labs to a commercial manufacturing site. It involves detailed documentation, process validation, and close collaboration between R&D and manufacturing teams to ensure the product can be produced consistently at scale.
Can you work with both small biotech firms and large pharmaceutical companies?
Yes. We tailor our project management and communication styles to fit the needs of our clients, whether they are a virtual biotech company requiring extensive guidance or a large pharma organization with established internal teams.
How do you ensure regulatory compliance throughout the process?
Regulatory compliance is at the core of everything we do. We operate under strict GMP guidelines, follow ICH recommendations for development and stability, and meticulously document every stage of the process to build a robust data package that meets the stringent requirements of agencies like the FDA and EMA.
Transforming a successful product to meet the needs of new patients is a powerful strategy for growth. If you’re facing challenges with patient adherence or looking to expand your product’s reach, our expert team is ready to help you navigate the complexities of reformulation. Start Your Custom Formulation Project Today and unlock the full potential of your drug product.
