Mega Aid’s collaborative research and development best practices address the full life cycle of a compound therapy treatment plan, enabling the company to produce effective, safe and high quality compounds to treat specific medical conditions.
Developing Compound Formulations is a Multi-Discipline, Collaborative Process. A number of individuals across Mega Aid are involved in the R&D cycle for our patient-specific compound formulations, including Compounding and Clinical Pharmacists, Pharmacist Interns, Pharmacy Technicians, Equipment Operators, Production Supervisors, Patient Services Specialists, Quality Assurance Specialists, and Compliance Specialists.
We often modify an existing formulation to suite the needs of an individual patient. Several factors can potentially drive changes to the specification of an existing, previously dispensed compound formulation, in order to produce a new compound whose formulation is best for a particular patient. These factors include:
As illustrated below, Mega Aid’s formulation specification, development and production cycle begins “upstream” in formulation workshops with physicians and/or groups of specialists. Here, Mega Aid’s clinical pharmacists, compound pharmacists, and pharmaceutical liaisons work with physicians to develop feedback, insight and direction to a formulation’s specification and expected clinical efficacy, testing, production, and post-dispensing product evaluation activities.
The context of these design consultation sessions with physicians is to review the efficacy, performance, reliability and quality of our compound formulation products and to solicit their ideas and request for new products or product changes. Thus the objective of these consultation sessions is to:
At the downstream end, after a product is dispensed to a patient, we assess the function, performance, reliability and quality of the “as-delivered” formulation.
The production elements of a formulation include various FDA-approved ingredients, the laboratory and manufacturing processes and specification which control the blending, and mixing of these ingredients into patient-specific compound formulation products, and lastly, various specifications which address the use, application, and safety precautions required when using the finished product.
Numerous process specification details exist to support the design, testing, production and dispensing. These process specifications address such items as:
In all formulation development, we document the clinical / therapeutic value, stability, safety and efficacy of each active ingredient, using articles and studies from journals and other credentialed sources.