Introduction to Pharmaceutical Dosage Form and Drug Delivery Systems PDF

31/08/2024 OUR LADY OF FATIMA UNIVERSITY COLLEGE OF PHARMACY...

31/08/2024 OUR LADY OF FATIMA UNIVERSITY COLLEGE OF PHARMACY TOPICS: Valenzuela. Quezon City. Antipolo. Pampanga. Cabanatuan. Laguna PHARMACEUTICAL DOSAGE FORM 1. Introduction to Drugs and Pharmacy AND DRUG DELIVERY SYSTEMS PRELIM Name of Lecturer Instructor- College of Pharmacy Date COURSE FACILITATOR TIME OUTCOMES: CHECKLIST: ▪ Read course and unit objectives At the end of the session the ▪ Read study guide prior to class students will be able to: attendance 1. Demonstrate knowledge of the historical development of drugs and pharmacy ▪ Read required learning resources; refer to unit terminologies for jargons ▪ Proactively participate in discussions ▪ Participate in weekly discussion board (Canvas) ▪ Answer and submit course unit tasks You are encouraged to keep Required Textbooks: track of your own performance Allen, Loyd V. ed. Ansel's Lecture 60%: Pharmaceutical Dosage ▪ Prelim 20% Forms and Drug Delivery Systems, 9th edition, Phila. ▪ Midterm 20% : Lippincott Williams & ▪ Finals 20% Wilkins, latest edition (Lecture) ▪ Performance 35% OLFU Laboratory Manual in ▪ Capstone/Research – 5% Drug Delivery Systems (Laboratory) 1  31/08/2024 Watch these Videos: Watch these Videos: Topic 3 Topic 1 ◉ https://www.youtube.com/watch?v=YBAswFuRJMU&t=89s (Making ◉ https://www.youtube.com/watch?v=QpmsHMtRdyc (History of Medicine - How Tablets are Made) Pharmacy) ◉ https://www.youtube.com/watch?v=MO9CaQeVPKA (How to Make ◉ https://www.youtube.com/watch?v=i4Trcw0fAZY (What is a Divided Powders) Pharmacopeia?) Topic 2 Topic 4 ◉ https://www.youtube.com/watch?v=w3ykU52K-Hw (Drug Development ◉ https://www.youtube.com/watch?v=LPS6t_fD3Ro&t=12s (Delayed and Testing - Clinical Trials) release vs Extended release) ◉ https://www.youtube.com/watch?v=bctaWQTYHJc&t=183s ◉ https://www.youtube.com/watch?v=adfny1cfvkI&t=64s (Introduction to (Understanding Clinical Trials) Controlled Release Drug Delivery System) References: References: Alfonso, Genaro, Remington : The Archana, Gibaldi's drug delivery systems in Science & Practice of Pharmacy 22nd pharmaceutical care. Maryland : American edition, Phila. : Lippincott , 2013 Soc. of Health-System Pharmacist, Latest Edition Ansel, Howard C.,Pharmaceutical Aulton, Michael E., Aulton's Pharmaceutics calculations,., Philadelphia : Wolters The Design and Manufacture of Medicines., Kluwer Health Latest Edition Edinburg: Churchill Livingstone Elsevier. O`Neil, Maryadele J. The Merck Index Latest Edition 14th ed., USA: Merck and Company, Mohan, Pankaj.. Pharmaceutical Latest Edition Operations Management; Manufacturing for Competitive Advantage. NY: McGraw-Hill, Latest Edition References: OLFU VISION https://www.pharmacy.wsu.edu/history/A%2 To improve man as man by developing 0History%20of%20Pharmacy%20in%20Pict individuals through a legacy of excellent ures.pdf education and compassionate value http://www.usp.org/sites/default/files/usp_pd formation. f/EN/USPNF/transdermalStimArticle.pdf http://www.fda.gov/Drugs/DevelopmentAppr ovalProcess/Manufacturing/ucm090016.htm http://www.safemedication.com/safemed/Me dicationTipsTools/ 2  31/08/2024 OLFU Graduate OLFU MISSION Attributes The noble dictum “improving man as man” A– Aspires To Do His Best embodies the existence of Fatima Medical C– Is Credible And Compassionate H– Is Hardworking And Honorable Science Foundation and Our Lady of Fatima I– Is An Inspiration To Others University as educational institutions E– Is Efficiently Entrepreneurial And dedicated to the holistic formation of men Employable and women imbued with the necessary V– Is A Visionary skills, virtues and academic development E– Is Ethical And Has Excellent Work Habits R– Is Responsible OLFU Core Values COP MISSION R - Respect The College of Pharmacy is committed to prepare I - Integrity students to become ethical, professionally S - Service E - Excellence competent, research and community service-oriented and environmentally conscious pharmacists by providing responsive curriculum, quality and innovative instruction, relevant practicum experience, and appropriate research and support activities PROGRAM/STUDENT COP VISION OUTCOMES By the time of graduation, the student should: The College of Pharmacy envisions being a Demonstrate knowledge and skills required topnotch provider of excellent education in the practice of pharmacy in the community, to future pharmacy professionals through its hospital and industrial pharmacy setting compliance with industry standards Use the techniques and skills and apply principles of scientific enquiry in the conduct of research relevant to pharmacy practice Demonstrate an ability to conduct, analyze and interpret experiments 3  31/08/2024 Use effective verbal, non-verbal, listening Work effectively as an individual and as and written communication skills to a leader, member of the pharmacy communicate clearly, precisely and appropriately with the health care staff, patients, carer, family team and of a multidisciplinary team relatives and clients/customers Demonstrate an ability to understand Apply knowledge on health promotion, disease prevention and control, and healthy lifestyle and professional, ethical and social wellness responsibilities Demonstrate understanding of ethical and Recognize the importance of lifelong legal principles related to pharmacy practice learning for pharmacists PROGRAM EDUCATION OUTCOMES Three to five years after graduation, graduates of the Bachelor of Science in Pharmacy at Our Lady of Fatima University are expected to: Introduction to Drugs and Pharmacy Practice as successful and responsible licensed pharmacists Participate in, or serve as an officer of, a local, regional, or national professional pharmacy organization, to advance professional and organizational goals. Engage in continuous learning and professional development. DRUG Drug a medicine or other substance which has a physiological effect when ingested or otherwise introduced into the body. Therapeutic agent; any substance, other than food, used in the prevention, diagnosis, alleviation, treatment, or cure of disease. 4  31/08/2024 Drug Action/Uses A substance recognized by an official Analgesics/antipyretic/Anti inflammatory pharmacopoeia or formulary. A substance Anesthetics intended for use in the diagnosis, cure, Antihypertensive Antineoplastic mitigation, treatment, or prevention Antipsychotic of disease. A substance (other than food) Cardiac drugs intended to affect the structure or any function of the body. Diuretics Antibacterial Antiviral Development of Drugs for cough and colds Hemostatics The Practice of GIT Drugs Drugs for Respiratory system Pharmacy Hypnotics and sedatives Before the Dawn of Pharmacy in Ancient History Babylonia Ancient man learned Practitioners of healing from instinct of this era (about 2600 B.C.) were priest, pharmacist and physician, all in one 5  31/08/2024 Pharmacy in Ancient Days of the Papyrus China Ebers An emperor (Shen The best known and nung) who sought out most important and investigated the pharmaceutical record medicinal value of is the "Papyrus several hundred herbs Ebers" (1500 B.C.), a. collection of 800 prescriptions, First Pen -Tsao mentioning 700 drugs. Papyrus Ebers Papyrus Ebers a continuous scroll some 60 ft. long and a foot wide dating back the 16th century BC Georg Ebers discovered and translated portions of the scroll Hippocrates Greek physician Hippocrates Theophrastus who is credited His observations and with the writings dealing with introduction of the medical qualities scientific and peculiarities of herbs are unusually pharmacy and accurate, even in the medicine. light of present (pharmakon) knowledge Known as the Father of Known as the father medicine of Botany 6  31/08/2024 Dioscorides Claudius Galen Greek physician and Greek pharmacist-physician botanist who was the first to who attained roman deal with botany as an citizenship. applied science of pharmacy. He originated so many preparations of vegetable He is the father of Medicinal drugs by mixing and melting Botany - Galenic Pharmacy. De Materia Medica which led His most famous formula, to the development of pharmaceutical botany and the cold cream, is called study of naturally occurring medicinal plants (pharmacognosy). Galen’s Cerate Damian and Monastic Cosmas Pharmacy Pharmacy's Patron Saints who Remnants of the symbolizes the Western knowledge of Pharmacy and twinship of the Medicine were health professions, preserved in the Pharmacy and monasteries Medicine The First Separation of Apothecary Pharmacy and Shops Medicine Pharmacy was officially The Arabs separated from medicine for the first separated the arts time in 1240 AD, when of apothecary and a decree of Emperor physician, Frederick II of establishing in Germany regulated the Bagdad late in the practice of pharmacy eighth century the within the part of his kingdom first privately owned drug stores 7  31/08/2024 Philadelphia College of Pharmacy The First Official Pharmacopeia Faced with two major threats; deterioration of the The idea of a practice of pharmacy, and a pharmacopoeia with official discriminatory classification status, to be followed by all by the University of apothecaries, originated in Pennsylvania medical Florence faculty, the pharmacists of The Nuovo Receptario, Philadelphia convened and originally written in Italian, signed the constitution of was published and became the first school of pharmacy the legal standard for the (established in 1821) city-state in 1498 First Hospital in The US Colonial America's Colonial America Pharmacopeia first hospital was The first American established in pharmacopeia was the so- Philadelphia in called Lititz Pharmacopeia, 1751; the first published in 1778 at Lititz Hospital Pharmacy The first "United States began operations Pharmacopoeia" (1820) there in 1752 was the work of the medical profession. First Hospital It was the first book of drug Pharmacist was standards from a Jonathan Roberts professional source to have achieved a nation's acceptance. Aureolus Philipus 1600’s – manufacturing Theophrastus companies Bombastus von 1800’s – researches Hohenheim were conducted 1877- Pasteur observed antibiotic Also called activities Paracelsus 1929 – Fleming A Swiss physician discovered Penicillin and chemist who And developed by introduced chemical Florey and Chain in science from the 1940 traditional botanical science 8  31/08/2024 Karl Wilhelm Friedrich Scheele Serturner Greatest of the German pharmacist Pharmacists-Chemists who isolated Discovered the morphine from following organic acids: opium lactic, tartaric, citric, oxalic, and also the He recognized and arsenic acid, he proved the importance identified glycerin, of a new class of invented new methods organic substances: of preparing calomel alkaloids. and benzoic acid. Caventou and Pelletier Pierre Robiquet In 1820 Caventou and Pelletier announced the methods for He isolated separation of quinine codeine from and isolated cinchonine opium from the cinchona barks and strychnine and Together with brucine from nux vomica Pelletier isolated caffeine Drug Standards Pharmacopeias/ Formularies Organized sets of The scientific basis for monograph or drugs and drug products books of these standards. developed. To ensure quality 9  31/08/2024 Official Compendia Official Compendia The term pharmacopoeia 1580, the term was first comes from the Greek used in connection with a word “pharmakon” ( drug) local book in Italy and “poiein” (make) 1864, the first British Pharmacopoeia Official Compendia Official Compendia In US, the first American In 1817, Dr. Lyman Spalding pharmacopoeia was a 32-page booklet proposed the creation of containing information on 84 internal and 16 external drugs and national pharmacopoeia. preparations published in 1778 He was called “the Father of USP” 59 60 ▪ 1888 - The first edition of National Formulary of ▪ January 1, 1820 - conducted Unofficial Preparation was published. the first United States Pharmacopeia Convention ▪ June 30, 1906 - President Theodore Roosevelt assembled in Washington, D.C. signed into law the first Federal Pure Food and Drug Act and changed the title to National ▪ December 15, 1820 - the first Formulary, designating both USP and NF United States Pharmacopeia was published in English and as establishing legal standards for medical and Latin. pharmaceutic substances. 10  31/08/2024 61 62 1975, the United States Pharmacopeial In 2002 - USP 25/NF20, the pharmacopeia will Convention, Inc. Purchased the National be published annually. Formulary, unifying the official compedia and thereby provided the mechanism for single, national compedium. USP/NF is released every November and made official on May of the next year. July 01, 1980 - The first combined compedium, representing the USP XX and NF XV became 2019 edition of USP/NF is ___________ official. Pharmacopoeia Monograph 1. Official title The official compendium 2. Synonyms 3. Chemical formula contains drug 4. Purity rubric 5. Packaging and storage monographs which 6. Reference standards assured availability of 7. 8. Labeling identification and preparation before use quality drugs and 9. Identification 10. Assay pharmaceutical products. Drug Regulation and Control Other Pharmacopeia June 30, 1906 - President Theodore ▫ IP Roosevelt signed into law the first Federal ▫ HPUS ▫ BP Pure Food and Drug Act. And he ▫ EP designating both USP and NF as ▫ JP establishing legal standards for medical and pharmaceutic substances. prohibited misbranded and adulterated food and drugs in commerce. 11  31/08/2024 Drug Regulation and Control deaths Solventof – more than diethylene Drug Regulation and Control 100 people glycol in 15 states Federal Food, Drug and Cosmetics Act of Kefauver – Harris Amendment 1938 (p. 11) ▫ Initiated by the 1960 Thalidomide tragedy ▫ Due to sulfanilamide incident ▫ Marketed as (Kevadon) an OTC for sedation ▫ Requires filing of NDA (New drug ▫ Requires filing for IND prior to NDA Application) ▫ Enacted to ensure greater degree of safety for Assures products are safe for human approved drugs and effectiveness use Drug Regulation and Control Drug Regulation and Control *Thalidomide is the standard treatment for the Durham-Humphrey Amendment of 1952 fever and painful skin lesions associated with ▫ Drug products were categorized into “Rx erythema nodosum leprosum (ENL), only” drugs and OTC multiple myeloma and cancer. ▫ Rx drugs may only be refilled upon consent of the prescriber Drug Regulation and Control Drug Schedule Comprehensive Drug Abuse Prevention and Sched II: accepted medical use, high potential Control Act of 1970 for abuse – may lead to psycho or physical abuse ▫ Control on drugs of abuse Morphine, cocaine,methamphetamine ▫ Led by DEA in DOJ ▫ Classified the controlled substances Sched III: medical use, less potential for abuse Sched I : no accepted medical use, high Codeine, hydrocodone potential for abuse Heroin, LSD,mescaline, marijuana 12  31/08/2024 Drug Schedule FDA Pregnancy Categories Sched IV: accepted medical use, low potential Category A: Adequate and well-controlled for abuse studies have failed to demonstrate a risk to Diphenoxin, diazepam the fetus in the first trimester of pregnancy (and there is no evidence of risk in later Sched V: accepted medical use, low potential for abuse trimesters). Dihydrocodeine, diphenoxylate Ex: Iron supplements, Levothyroxine sodium, Thyroid FDA Pregnancy Categories FDA Pregnancy Categories Category B: Animal reproduction studies have Category C: Animal reproduction studies failed to demonstrate a risk to the fetus, and have shown an adverse effect on the there are no adequate and well-controlled fetus and there are no adequate and studies in pregnant women. well-controlled studies in humans, but Ex: Penicillins and Cefalexins, Tranexamic potential benefits may warrant use of the acid, Ibuprofen drug in pregnant women despite potential risks. Ex: Digoxin, Dopamine, Guiafenesin FDA Pregnancy Categories FDA Pregnancy Categories Category D: There is positive evidence of Category X: Studies in animals or humans human fetal risk based on adverse reaction have demonstrated fetal abnormalities and/or data from investigational or marketing there is positive evidence of human fetal risk experience or studies in humans, but potential based on adverse reaction data from benefits may warrant use of the drug in investigational or marketing experience, and pregnant women despite potential risks. the risks involved in use of the drug in pregnant women clearly outweigh potential Ex: Antineoplastics, atenolol benefits. Ex: Hormones such as estrogen, testosterone 13  31/08/2024 Prescription Drug Marketing Act Other Laws 1987 Drug Listing Act The act is intended to reduce the risks of Drug Price Competition and Patent adulterated, misbranded, repackaged, or Restoration Act mislabeled drugs entering the legitimate Prescription Drug Marketing Act 1987 marketplace through “secondary sources.” Dietary Supplement Health and Education Act FDA Modernization Act Drug Price Competition and FDA Modernization Act Patent Restoration Act Expands the capacity of FDA in regulating Applications for generic copies of an originally pharmacy standards and practices approved new drug can be filed through an abbreviated new-drug application (ANDA) Dietary Supplement Health and Drug Listing Act Education Act Provide the FDA with the legislative authority Regulate the labeling claims made for to compile a list of marketed drugs to assist in these products such as the the enforcement of federal laws requiring that vitamins, minerals, amino acids, and drugs be safe and effective and not botanicals adulterated or misbranded 14  31/08/2024 Drug Product Recall Question Class I – cause serious adverse effects or 1. Written scroll containing lists of herbal death drugs Class II – cause temporary or medically 2. Father of medicinal botany reversible adverse health consequences 3. Discovered the papyrus ebers Class III – not likely to cause adverse health 4. Chinese emperor who studied various consequences herbal plants 5. Discovered several oRGanic acids 6. Isolated caffeine Thank you! Any questions? 7. Isolated morphine 8. Introduce scientific pharmacy You can find me at: [email protected] 9. Greek word for DRUG 10. Father of medicine #RisetotheTOP 88 15