CHAPTER 2: INTRODUCTION TO NUTRACEUTICALS, NUTRACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS NOOR MUHAMMAD SYAHRIN BIN YAHYA LEARNING OBJECTIVES The objectives of this unit are to: §Understand theory behind the production of nutraceutical. §Understand nutraceutical dosage forms and drug delivery systems. LEARNING OUTCOMES After completing this unit, student should be able to: §Describe drugs and pharmacy practice. §Explain new nutraceutical development and process. §Produce quality nutraceutical product base on current Good Manufacturing Practices and Good Compounding Practices. DEFINITION NUTRACEUTICAL: § Merriam-webster: § Definition: a foodstuff (such as a fortified food or dietary supplement) that provides health benefits in addition to its basic nutritional value. § Medicine definition: a foodstuff (as a fortified food or a dietary supplement) that is held to provide health or medical benefits in addition to its basic nutritional value—called also functional food § Wikipedia: § A Nutraceutical is a pharmaceutical-grade and standardized nutrient. In the US, "nutraceuticals" do not exist as a regulatory category; they are regulated as dietary supplements and food additives by the FDA under the authority of the Federal Food, Drug, and Cosmetic Act. § MedicineNet.com: § A food or part of a food that allegedly provides medicinal or health benefits, including the prevention and treatment of disease. A nutraceutical may be a naturally nutrient-rich or medicinally active food, such as garlic or soybeans, or it may be a specific component of a food, such as the omega-3 fish oil that can be derived from salmon and other cold- water fish. INTRODUCTION § Nutraceuticals are food extracts that have been demonstrated to produce a physiological benefit or provide some protection against chronic disease. § As the name implies, nutraceuticals are the intersection of nutrition and pharmaceutical and is an umbrella term that can also include functional foods and dietary supplements. § In the same way that the particle size and shape distributions of active pharmaceutical ingredients and drug delivery systems effect their solubility and bioavailability, so is particle characterization critical to nutraceuticals. § Laser diffraction particle size analyzers offer the same benefits in speed, precision, and reliability to nutraceutical materials that have made the technique popular in the pharmaceutical industry. CHAPTER 2: INTRODUCTION TO NUTRACEUTICALS, NUTRACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS 2.1: INTRODUCTION TO DRUGS AND PHARMACY 2.1: INTRODUCTION TO DRUGS AND PHARMACY § Pharmacy has historic roots as the art and science of preparing and dispensing medications. qWhile this traditional role is still a viable role for pharmacists, the preparation of medicines has transitioned in large part to the pharmaceutical industry. § Dispensing of medicines has increasingly become more centralized and automated, with many of the tasks formerly per- formed by pharmacists being done using technology or delegated to pharmacy technicians. § The provision of drug-related information to other healthcare professionals and the public and disease-state management programs to assure the proper use of medicines has become a more important role for pharmacists. § It is now recognized that medication-use is a complex and problem-prone process, in which errors that result in injury to patients can occur at each step. § This process includes prescribing, transcribing, interpretation of the order, preparation and dispensing, and administration and monitoring. 2.1: INTRODUCTION TO DRUGS AND PHARMACY § It has been estimated that more than 2 million hospitalized patients per year experience an adverse drug reaction, two thirds of which were the cause of hospital admission and more than 100,000 of which are fatal. § For pharmacists to contribute to improving the value of medicines, they must have a role in every aspect of medication use, from preparation to monitoring the outcome of drug therapy. § Pharmacy practice therefore involves the review and interpretation of prescription orders; the compounding, labeling, and dispensing of drugs and devices; drug product selection and medication-use evaluation (MUE); patient monitoring and intervention; and the provision of information related to use of medications and non- pharmacological modalities. 2.1: INTRODUCTION TO DRUGS AND PHARMACY § Pharmaceutical care holds that the important role of the pharmacist is q‘‘the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient’s quality of life.’’ § Pharmacists are experts on medications. § They are also the most accessible member of today’s healthcare team, and often they are the first source of assistance and advice on many common ailments and healthcare matter. CHAPTER 2: INTRODUCTION TO NUTRACEUTICALS, NUTRACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS 2.2: NEW NUTRACEUTICAL DEVELOPMENT AND APPROVAL PROCESS 2.2: NEW NUTRACEUTICAL DEVELOPMENT AND APPROVAL PROCESS § Generally the goals of nutraceutical regulation have been focused on safety and labeling with lesser emphasis (as compared to pharmaceuticals) on product claims and intended use. This is achieved through Good Manufacturing Practice (GMP) regulations and a recent increase in enforcement. 1. Consumers are largely responsible for determining the usefulness and value offered by nutraceutical products, although regulatory agencies are increasingly enforcing industry requirements that call for nutraceutical companies to track adverse events. 2. There is consensus among nutraceutical companies that increased regulation related to quality and safety will benefit the industry, and help mitigate the risk of regulatory backlash if scrupulous players engage in abusive practices and are left unchecked. 3. Greater enforcement of GMP regulations are likely to drive further consolidation in the relatively young, fragmented industry as those lacking proper scale are unable to comply with the greater emphasis on regulation or make the necessary investments to become compliant across multiple jurisdictions. 2.2: NEW NUTRACEUTICAL DEVELOPMENT AND APPROVAL PROCESS The Nutraceutical Market (World) § Bourne Partners released an April 2013 Nutraceutical Sector Report (free download) that put the global nutraceutical market at $142 billion in 2011. § With an estimated growth rate of 6.4% (CAGR), the market is expected to reach $204.8 billion by 2017. § Growth is being driven by favorable demographics, increases in disposable income, rising healthcare costs and an increasingly robust OTC market. § In developing nations, the middle classes are growing, which translates to increased disposable income because of typically regressive tax structures. § Also, developing nations are increasingly becoming the preferred source for cheaper raw material supply found in many nutraceutical products. **Compound Annual Growth Rate (CAGR) **Over The Counter (OTC) 2.2: NEW NUTRACEUTICAL DEVELOPMENT AND APPROVAL PROCESS § Classifications and Definitions § Part of trying to better understand the regulatory environment begins with defining nutraceuticals, which are also referred to as dietary supplements – a term preferred by the US Food and Drug Administration (FDA). § For the purposes of this discussion, nutraceuticals can be thought of in a broad sense as a food, food derivative or food product, usually in extracted form, that reportedly provide health or medical benefits, including the prevention and treatment of disease. Such products may range from isolated nutrients, dietary supplements, herbal products and specific diets to genetically engineered foods and processed or supplemented “functional” foods such as cereals, soups, and beverages. § Often used interchangeably to describe “nutraceuticals” are “dietary supplements”, which include vitamins, minerals, herbs, botanicals, amino acids, fatty acids and probiotics. For the purposes of this discussion, we will use nutraceuticals to refer to all of the above categories. The below chart from Frost & Sullivan’s report, “Global Nutraceutical Industry: Investing in Healthy Living,” provides a helpful overview of the different nutraceutical classifications 2.2: NEW NUTRACEUTICAL DEVELOPMENT AND APPROVAL PROCESS § Regulation Background & Recent Trends § Nutraceutical foods are not subject to the same testing and regulations as pharmaceutical drugs. The aim of nutraceutical regulation is largely to ensure products are safe and properly labeled. § It’s important to note that nutraceuticals do not face the same level of scrutiny as pharmaceuticals in regards to product claims and intended use. There is a perception that this lack of oversight leads to products of variable quality and with claims of questionable merit. Unfortunately for the nutraceutical industry, this perception was reinforced in an April 2013 Research Letter published online in JAMA Internal Medicine. As reported in the letter, FDA data showed supplements were involved in half of all drug recalls. More specifically, 51% of Class I recalls over a 9-year period involved adulterated dietary supplements instead of a pharmaceutical product. § Sexual-enhancement aids were the most commonly recalled product (40%), followed by body- building (31%) and weight-loss products (27%). Nine out of 10 (89%) supplement recalls occurred after 2008, and unapproved drug ingredients were involved in all of the supplement recalls. § The study was limited since it only accounted for Class I recalls,