The Magnesium Stearate Handbook
by
Book Cover & Preview Text
As magnesium stearate (MgSt) continues to be the excipient of choice for pharmaceutical solid oral dose blends its proper use can sometimes be diverted due to attractive claims associated with rectifying tablet quality issues. The best use of MgSt is commonly misunderstood and often misused particularly when tablet issues arise such as tool binding during the compression cycle. It is often utilized to address picking problems. Picking is the adherence of powder in the corners and/or island of a logo embossed on the punch face. Characters such as A, D and O and numerals such as 4, 6 and 8 are often problematic. If minor picking problems are not addressed properly then typical picking may escalate to a more serious tablet defect known as sticking. Sticking may result in unacceptable tablet appearance and in severe cases may cause weight and content uniformity issues. Hence, the utilization of MgSt as a quick and easy solution to simple tablet manufacturing problems may result in or contribute to not readily foreseeable problems with effectiveness of a given medicine. Development and delivery of a pharmaceutical oral dosage blend demands a quality by design (QbD) approach. Understanding the assembly of the active pharmaceutical ingredient with its associated fillers, binders, lubricants, glidants and disintegrant requires a thorough knowledge of the function of each component and the impact of each component on the safety, integrity, strength, purity and quality of the tablet delivered to the patient. MgSt is one of the most popular lubricants utilized in the pharmaceutical tablet manufacturing industry. The physical properties of MgSt determine its impact on the properties of the bulk powder of which it is a component, the compression strength of tablets made with that powder and ultimately the stability and bioavailability of the therapeutic molecule being delivered to the patient. The reality is that MgSt has a variety of available polymorphs to go along with an array of particle size distributions. The lot to lot variability of these physical properties and others discussed in this book can impact the product being manufactured. A properly designed experimental assessment of different blend manufacturing techniques requires acknowledgement of these differences and the understanding of potential implications of this excipient variability. This book offers the reader insight into the physical and chemical properties of a tablet component all too often overlooked in the design of the formulation. Dr. Patrick Okoye has invested a significant portion of his career as a pharmacist and researcher in pursuit of a comprehensive understanding of the role of MgSt in pharmaceutical dosage forms. Dr Patrick Okoye work provides measurements of the chemical and physical properties of the different forms of MgSt along with an overview of the impact of MgSt on powder rheology. In addition, studies of the impact of MgSt on tablet physical properties and active pharmaceutical ingredient dissolution are provided. There is a wealth of information in this book and its references which will assist any formulator concerned with the selection and use of MgSt as a lubricant in a pharmaceutical, cosmetic or food presentation. Dale Natoli DSc h.c. President/Ceo Natoli Engineering
Formats
Book Details
About the Book
Magnesium stearate (MgSt) is widely used in cosmetic, food, and pharmaceutical formulations as lubricant in capsule and tablet manufacture at concentrations between 0.25% and 5%. A recent review of the top two hundred prescription drugs showed over 50% contained magnesium stearate. This book covered a broad spectrum of concentration from 1% to 10% for the purpose of presenting their unique properties during powder rheology, tableting, and effect on drug dissolution. MgSt also has both scientifi c and economic signifi cance, given its wide application in global pharmaceutical manufacturing. An understanding of polymorphism (or pseudopolymorphism) in magnesium stearate and the impact on tablet lubrication process and drug dissolution would provide a valuable tool to pharmaceutical scientists during excipient selection process for new product development and even during reformulation of existing products. Preformulation scientists spend a great deal of time reviewing excipients for new product development both in silico and on the bench. As a result, accurate selection of excipients, such as lubricants, could avoid potential issues with clinical batches, product scale-up, and product transfer during commercialization.
About the Author
Dr. Patrick C. Okoye is the founder and CEO of Griffin-Gamma LLC., a consulting firm that specializes in product development, quality systems development and recovery, product certifications, and renewable energy.
As a research pharmacist, Dr. Okoye has spent over two decades studying powder lubrication and magnesium stearate. Dr. Okoye worked at various levels in the pharmaceutical industry including manufacturing, technical services, drug formulation, regulatory compliance, and quality systems. He also served as senior executive in skincare and cosmetic manufacturing and packaging.
Dr. Okoye is an adjunct faculty member at Nebraska Institute of Forensic Sciences. He also serves on the advisory board of Afrimerica Global Missions, a nonprofit philanthropic organization.
Dr. Okoye earned his bachelor of pharmaceutical sciences from Nigeria, followed by a master’s of science in industrial pharmacy and cosmetic science from Long Island University, New York. He received his doctorate in pharmaceutics from Long Island University, New York. Dr. Okoye is also a certified pharmaceutical regulatory specialist.
Dr. Okoye has many peer-reviewed publications in numerous scientific journals including book chapters in pharmacokinetics and postmortem drug redistribution.