This practice-based activity is divided into four sections: modern facility design concepts for non-hazardous and hazardous compounding, establishing a strategic collaborative practice model, working with advanced drug delivery systems, and quality controlled compounding.

The activity begins by discussing modern facility design concepts in adherence with current standards of practice. It explores advantages and disadvantages related to the design of compounding facilities for non-hazardous and hazardous drug compounding and explores the many variables that impact facility design, including functional and operational parameters of secondary engineering controls (SECs), containment-secondary engineering controls (C-SECs), primary engineering controls (PECs), and containment-primary engineering controls (C-PECs). Furthermore, factors that impact functional and operational performance measures will be used to establish design strategies for an efficient and effective facility design. Participants will be given the opportunity to complete a questionnaire that helps summarize the parameters of a compounding practice, in order to define their own facility requirements. Next, participants will engage in designing an advanced facility workflow schematic for a non-hazardous and hazardous practice. Additional factors that will be taken into account include positive and negative pressure, air pressure differentials, air changes per hour (ACPH), air velocity, air reuptake, and HEPA filter coverage requirements for air exhaust systems.  

The focus then shifts to challenging the compounding pharmacist to examine a clinically-based, collaborative strategy that will redefine the pharmacist, physician and patient relationship. Participants will explore niche market-specific, collaborative clinical assessment profile variables in an effort to increase communication and interaction with prescribers.  This will help solidify relations, build confidence with prescribers, build an evidence-based database in support of the compounding practice, and bring a clinical superiority to the patient care challenge.

Next, drug delivery systems will be reviewed and innovative research outlining novel concepts in bioavailability optimization for poorly absorbed (large and/or lipophilic) drugs is presented; delivery systems for oral, rectal, and topical dosage forms are discussed. This can provide the compounding pharmacist with a clear advantage in the marketplace. A comprehensive set of factors that impact bioavailability is examined in detail. Each route of delivery will then be further examined, focusing on topical, oral, and rectal routes. Relationships are defined and established between drug agent, barrier to absorption, and base/delivery system. The criteria for utilization and scientific are outlined followed by the demonstration of advanced delivery systems. Each route of delivery is then assessed for its respective factors that impede absorption and the corresponding solution to the obstacle presented.

Datasets from quantitative structural activity relationships (QSARs) are used to identify functional characteristics of drug agents. The n-Octanol-water partition coefficient, permeability coefficient, diffusion coefficient, and distribution coefficient each reveal unique characteristics or potential activity of drug agents across barriers to absorption. Details are provided on Hydrophilic-lipophilic balance (HLB) and pH manipulation in order to increase permeation. Permeation-enhancing agents, surfactants, and emulsifying agents are brought together to form the basis of the advanced delivery system. The interrelationship between these agents, held together at specific concentrations, results in a relative polarity index conducive to enhanced permeation. The delivery system utilizes and interacts with physical structures within the barrier to absorption to create an opportunity for improvement in permeability, without deleterious side effects to the barrier itself. The result is a potential for improvement in clinical outcome, potential for reduction in drug concentration requirements in the formulation, and a potential for reduction in deleterious side effects to the patient.

The next topic emphasizes an all-important aspect of a compounding practice, Quality Controlled Compounding (QCC). QCC can be divided into three sub-categories: efficacy, reliability, and validity. These three sub-categories are applied to specific pharmaceutical calculations, personnel performance assessment, and process verification, all of which increase the quality assurance and quality control of finished, compounded preparations. Each of the three sub-categories will be further subdivided, allowing the participant to apply a broad range of analytical parameters to the developmental process for a master formulation record, which includes our newly-defined, advanced drug delivery systems.