The pharmaceutical industry is evolving, with a growing need for specialized formulation development and manufacturing services. Piramal Pharma Solutions (PPS) is adapting to these changes by expanding its global R&D and manufacturing footprint. In a recent Q&A, Brad Gold, global formulations R&D head, and Sundar (Sunny) Neelakantan, director of development, discussed the latest advances in high-potency oral solid dosage (OSD) forms, controlled-release platforms, sterile injectables, and patient-centric dosage forms.
PPS has established a dedicated site in Ahmedabad, India, to provide rapid development and clinical trial material manufacturing for Phase I and II drug programs, particularly for orphan and niche assets. The company is also investing in new technologies, such as multi-layer tableting and tablet-in-tablet technology, to improve formulation development and manufacturing efficiency.
In terms of high-potency OSDs, PPS is using continuous processes, such as dry granulation and roller compaction, to formulate and manufacture potent drugs. The company is also employing containment design and process equipment to ensure safe handling and processing of these drugs.
PPS is also developing controlled-release platforms, including sustained-release, zero-order, and near zero-order release formulations. The company holds patents around these technologies and is using them to deliver drugs more efficiently to the body.
To ensure consistency in formulation quality, knowledge transfer, and risk reduction, PPS is using an integrated and multi-site Stage Gate approach to product development and commercial readiness. The company is also employing operational excellence modules, lean, and QbD principles across its multi-site R&D network.
In terms of patient-centric dosage forms, PPS is developing flexible dosage forms, such as chewable tablets, sprinkle capsules, and minitablets, to address the needs of different patient populations. The company is also using taste-masking technology and other formulation strategies to improve patient compliance and outcomes.
PPS’s global footprint, with formulation sites in the US, UK, and India, is a core differentiator. The company is using its Stage Gate approach and SUPAC guidance to coordinate formulation development and manufacturing across these geographies, ensuring compliance, consistency, and quality.
Finally, PPS is positioning its formulation R&D capabilities to support newer classes of therapies, such as peptides, oligonucleotides, and other complex modalities. The company is investing in new equipment and technologies, such as high-pressure homogenizers and high-pressure extruders, to develop and scale up these complex formulations. PPS is also enhancing its analytical capabilities to characterize and test complex matrices and understand degradation pathways.