Compound Formulation R&D

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 Formulations is a Multi-Discipline, Collaborative Process

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:

  • The physical and biological sciences related to treating the better-known aspects of a particular medical condition, or combination of conditions.
  • A variety of other patient-specific factors, which have implications from a physical and biological sciences perspective, and which could therefore impact the formulation specification. These factors include:
    • A patient’s physical profile and overall health
    • Individual and family and medical history
    • Known drug tolerances, allergies or sensitivities
    • The health condition of specific organs
    • Gastrointestinal issues
    • Physical limitations or physiological considerations
    • Potential environmental or work-place factors
Understanding Our Research and Development Life Cycle

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.

R and D life cycle

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:

  • Review a formulation’s specification design, including mechanisms of action, adverse side effects, drug interactions, etc.
  • Identify new clinical / therapeutic requirements and potential compound formulation products to address these requirements
  • Identify / request changes to current formulations based on research and the results of Mega Aid’s own post-dispensing testing of its formulations by labs, or interviews with patients
  • Review recently published research findings regarding formulation ingredients
  • Review Mega Aid’s statistical and anecdotal findings on patient satisfaction, as well as performance and reliability of its dispensed compound formulations

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.

  • While some of this data is obtained from independent testing laboratories, the majority is gathered by Mega Aid’s team of patient services representatives.
  • These individuals are trained to interview patients across a number of dimensions to gather data that then feeds back to our formulation specification, testing and production teams, as well as all the way upstream to the clinical and liaison teams as input for their formulation consultation sessions with prescribing physicians.
We Apply Rigorous Quality Assurance Measures to our Formulation Production Processes

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:

  • Inactive Ingredients
  • Active Ingredients
  • Ingredient Concentrations
  • Form (liquid, powder, gel)
  • Compound formulation specification
  • Equipment mixing / milling / packing
  • Dispensing Quantities
  • Application Instructions
  • Device / Container

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.