Description

With personalized medicine on the exponential rise, the compounding industry is experiencing significant growth and demand due to its unique ability to customize pharmaceutical preparations meeting patient-specific needs. Along with this growing demand, the successful compounding pharmacist is challenged by a number of operational and clinical parameters of practice.

Some operational challenges manifest themselves as an increase in volume of prescriptions containing the same active pharmaceutical ingredients (APIs) of the same or variable strength. Even the experienced compounding pharmacist may find themselves unable to manage this increased workload. This program employs strategies that address this operational challenge. From a clinical perspective, contemporary compounding oftentimes involves the use of larger and/or lipophilic molecules. The bioavailability of these molecules may present a challenge, as they are not easily absorbed. To compensate, specialized delivery systems can be employed. The above mentioned challenges require a practical skillset and tactical approach that meets prescriber and patient needs and improves practice efficiency and efficacy.

Expanding on the foundational knowledge taught in LP3 Network’s course, “The Science of Pharmaceutical Compounding – Non-Sterile Training” this program delves further into the complexities of managing a more robust non-sterile compounding practice.  In this training, participants will learn how to practically implement a new set of skills and strategies, and then apply them to process development (PD) requirements, stock formulation records (SFRs), master formulation records (MFRs), and compounding records (CRs). With this practical start-to-finish approach, experienced compounders will develop and use a new set of tools needed to make their compounding practice more financially profitable, more time and task efficient during day-to-day operations, and ultimately more reputable in their respective customized therapeutic areas of practice. In order to achieve this goal, the program is divided into a seminar and laboratory component.

SEMINAR COMPONENT

This is a 4-hour interactive seminar which features robust clinical due diligence practices, practical methods to optimize performance, advanced developmental and preparatory techniques, and new technology featuring automated calculations. These advanced tools and skills are applicable to powder blends; liquid-, semisolid-, and solid- filled capsules; semisolids delivered in actuated doses; and solid molded dosage forms.

Featured practical tools include:

• Preparatory methods, use, application, and automation for:
  • Stock powder blend aliquots
  • Stock powder-in-liquid aliquots and concentrates
  • Stock powder-in-semisolid aliquots and concentrates
• Specialized and refined preparatory procedures to save time and money
• Standard operating procedures (SOPs) for newly learned procedures
• Methods to easily populate a large number of MFRs
• Optimizing lipid-based delivery systems and self emulsifying drug delivery systems (SEDDS) for oral capsules
• Selecting synergistic permeation enhancing agent combinations for improved percutaneous absorption of APIs in transdermal dosage forms

LABORATORY COMPONENT

This is a 4-hour hands-on laboratory training where participants will learn how to incorporate stock powder-blend aliquots, and stock powder-in-liquid aliquots and concentrates using novel preparatory techniques, innovative technology, and having made use of automated calculations. Participants will experience labeling requirements for stock aliquots and concentrates. These aliquots and concentrates will be used to compound four dosage forms:

• Estradiol* 0.00025 g, Estriol* 0.001 g, Progesterone* 0.030 g Topical Cream prepared from a stock powder-in-liquid aliquot and a stock powder-in-liquid concentrate
• Naltrexone hydrochloride 0.0001 g, Methylcobalamin 0.001 g Oral Troche prepared from a stock powder blend aliquot
• Piroxicam 0.005 g / 0.48 mL Oral Liquid-Filled Capsule containing a self emulsifying drug delivery system
• Ketoprofen 0.0075 g / 0.15 mL Transdermal Cream prepared in a synergistic permeation enhancing agent delivery system, calibrated to an actuated volume, and contained in an actuated dose dispensing device

Participants will document key components of easy-to-use SFRs, MFRs, and CRs. Quantitative analyses of stocks and finished preparations will be conducted using automated calculations. Opportunities to perform quantitative and qualitative assessments, particularly for SFRs, will be revealed. Participants will adhere to specialized SOPs related to cutting-edge techniques and technologies.

Note: Formulas are subject to change.

* Drugs that are found on the National Institute for Occupational Safety and Health (NIOSH) list of Antineoplastic and Other Hazardous Drugs in Healthcare Settings will be replaced by non-hazardous drugs. Proper hazardous drug handling techniques and the correct use of personal protective equipment will be covered.