🔬 Why Reverse Engineering is Essential in Developing Complex Generic Formulations

In the development of complex generics, reverse engineering is not just a supporting tool — it is a critical scientific strategy. Unlike conventional formulations, complex generics often involve sophisticated drug delivery systems using polymers like PLGA (poly lactic-co-glycolic acid). These systems exhibit multiple levels of interactions, such as hydrogen bonding, van der Waals forces, and hydrophobic associations, which directly affect drug release kinetics and polymer degradation profiles.

Understanding these interactions requires more than just identifying the excipients — it demands a deep dive into the molecular behavior and structural attributes of both the drug and the carrier matrix.

🔍 What Makes Reverse Engineering Crucial?

In formulations involving PLGA and other biodegradable polymers, the performance of the drug product is influenced by a wide range of variables, including:

✅ Formulation Process Parameters – stirring speed (RPM), homogenization, emulsification techniques, drying methods, etc. ✅ Thermal Conditions – process temperature, heating/cooling cycles, thermal history. ✅ Solvent System – type, ratio, purity, and residual solvent content. ✅ Polymer Characteristics – monomer ratio (e.g., 50:50, 75:25), molecular weight, block structure (random vs. block copolymer), and terminal functional groups (acid or ester). ✅ Polymer Architecture – linear, branched, or star-shaped structures influencing degradation and drug entrapment. ✅ Drug–Polymer Interaction – nature of physical/chemical bonding that can govern drug encapsulation efficiency, release rate, and stability.

Each of these parameters plays a role in how closely a generic matches its Reference Listed Drug (RLD) — not just chemically, but functionally and structurally.

🧪 How Nomisma Healthcare Can Help

At Nomisma Healthcare, we specialize in reverse engineering and structural equivalency studies for complex drug products involving PLGA, PLA, PCL, and other bioresorbable polymers.

Our services include:

🔬 Product Sameness Studies 🔬 Polymer–Drug Interaction Analysis 🔬 Secondary Structure & Morphology Evaluation 🔬 Release Profile Comparisons with RLDs 🔬 Custom Polymer Matching Based on RLD Behavior

We don’t just replicate ingredients — we decode how and why the formulation performs, ensuring your generic meets regulatory expectations in Q1/Q2 equivalence, in-vitro performance, and long-term stability.

📩 Connect With Us Looking to develop a complex injectable, implant, or microsphere-based formulation?

👉 Reach out to us at: info@nomismahealthcare.com 🔗 Let Nomisma Healthcare be your strategic partner in reverse engineering and formulation innovation.