Introduction to Drugs and Pharmacy - Pharmaceutical Dosage Forms PDF

Here is the converted markdown format of the document: # Pharmaceutical Dosage Forms, Drug Delivery Systems, and Medical Devices New Drug Development and Approval Process ## Your role - You are a tool to convert images and documents into a structured markdown format. - Transcribe text. - Keep all...

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Prof. Sandra C. Sy, MSC * AY 2023-2024 * \1st Shifting ### OUTLINE 1. Drugs and Pharmacy 2. Heritage of Pharmacy 3. Drug Standards 4. Drug Regulation and Control 5. Federal Food, Drug, and Cosmetic Act of 1938 ## I.DRUGS AND PHARMACY * Drug * Agent intended for use in the diagnosis, mitigation, treatment, cure, or prevention of disease in humans or in other animals. * Articles or agents recognized in the USP-NF, the Homeopathic Pharmacopeia of the United States, the British Pharmacopeia. * Has diversity of actions and effects on the body * Mydriatic = dilate pupil / Miotic = constrict * New drug * Derived from plant or animal sources, as by-products of microbial growth, or growth through chemical synthesis, molecular modification, of biotechnology * Pharmaceutics * Branch of pharmaceutical sciences that deals with the process of turning new chemical entities into a dosage form ### Activities in the Field of Pharmaceutics * Investigation of physical and chemical properties of drug molecules. * Design, fabrication, and evaluation of drug delivery systems. * Monitoring how drug products are absorbed, distributed, metabolized, and excreted in the body ADME ### Branches of Pharmaceutics * Dosage forms (sociality) * Branch of pharmaceutics that deals with the formulation of active substances in combination with other drugs to produce a desirable dosage form based on its physical properties and intended use. * Physical pharmacy (Law) * Deals with the physicochemical principles underlying the design and development of a successful dosage form. * Pharmaceutical manufacturing (economy) * Process of making drug from raw material into finished products in an industrial scale. * Based on Current Good Manufacturing Practice * Pharmaceutical technology (Leadership) * Process of converting an active component into a drug product * Has three stages: * $1^{\text{st}}$ technology - process; creation of a technology to produce an active compound with good quality and in large quantity * $2^{\text{nd}}$ technology - formulation; drug manufacturing preperation from raw material until the final product with an optimal result * $3^{\text{rd}}$ technology - analytical and quality evaluation; ensuring the quality of the final drug product until it is used by the patient ## II. HERITAGE OF PHARMACY Drugs, in the form of vegetation and minerals, have existed as long as humans. * Diseases were believed to be caused by demons or evil spirits, thus, spiritual incantations and application of noisome materials were used to remove said spirits. ### A. THE FIRST APOTHECARY * Apothecary (the art of apote chary) originated from the preperation of medicinal Materials * Person who prepares and sells drugs or compounds for medicinal purposes in the early phases of history * Associated with the mysterious due to belief that there isa connection with spirits * Eventually merged with duties of priest * Pharmacy * From homerick epic * From the Greek word "pharmakon" meaninga charm or a drug that can be used for good or for evil * A place or shop where drugs or medicines are sold * A profession, the people who deal with the compounding and dispensing of drugs * Art and science of preparing and dispensing medication * Provides drug-related information to the public * Involves the interpretation of prescription orders ### B. EARLY DRUGS * Sumerian clay tablets * Found in 3000 BC * World's oldest writtens prescriptions * Lo contains ion propervation of the veed of carpenter, plant, gum resin of markhazi, & thyme * Ebers papyrus * Continuous scroll of 60 feetlong and a foot wide containing more than 800 fornulas and mentioning more than 700 drugs * Discovered by Georg Ebers * Lo discovered in a tumb of mummy * Lo botanical * $1.$ acacia * $2.$ castor bean * $3.$ Fennel * Lo mineral * $1.$ iron oxide * $2.$ Jodium carbonate * $3.$ sulpur * O Vehiales of the day * $1.$ beer * $2.$ whe * Lo animal dwg * $2.$ milk * $4.$ honey ## C. INTRODUCTION OF THE SCIENTIFIC VIEWPOINT * Hippocrates * Father of Medicine * Greek physician credited with the introduction of scientific pharmacy and medicine * Teachings are embodied in the Hippocratic oath of ethical behavior for the healing professions * pharmakon = purifying remedy for good only * Dioscorides * Gree physician and botanist who wrote De Materia Medica (milestone in naturally occurring medicinal materials) * pharmacognosy - study of natural products chemistry; from pharmakon and gnosis drug knowlege * described: opium, ergot, hyoscyamus * Claudies Galen * Greek pharmacist-physician who is credited for creating 500 treatises on medicine and other studies * Originated many preparations, now known as Galenic pharmacy to has vimilarities to theatrical cold creams. * Most famous is Galen's cerate or cold cream * Emperor Frederick II of Germany * Created a decree that separated pharmacy and medicine in 1240 AD * Aureolus Theophrastus Bombastus von Hohenheim * Father of Toxicology * Swiss physician who called himself *Paracelsus* * Transformed pharmacy from botany to chemistry ## D. EARLY RESEARCH * Karl Wilhelm Scheele * Most famous of all pharmacist * Discovered lactic, citric, oxalic, tartaric, and arsenic acid, glycerin up pormic qad * Invented new methods or preparing calomel and benzoic acid * Discovered oxygen **Famous Pharmacists Across History** * Friedrick Sertürner - isolated morphine from opium (1805) * Joseph Caventou and Joseh Pelletier - discovered quinine, cinchonin, strychnine, and brucine catchong nux Vomica * Pierre Robiquet and Pelletier - discovered caffeine * Pierre Robiquet - discovered codeine * PAUL EHRLICH - methylerebwe, plasmo gin & atabrin, & valvarzan isolated strychnine, bicine (From nux vomica) # 404 * MAGENDIE ### Table 1. Drugs from Plant Sources | Plant | Active Ingredient | Use | | :----------------------- | :---------------- | :-------------------------------------- | | Rauwolfia serpentina | reserpine | Tranquilizer and hypotensive drug | | Vinca rosea (periwinkle) | vincristine | Diabetes mellitus, cancer like leukemia | | Pacific yew tree | Pacilitaxel | Ovarian cancer | | Digitalis lanata | digoxin | cardiac glycoside | * Schools of Pharmacy * Royal College of Apothecaries - founded 1441; oldest college of pharmacy * Philadelphia College of Pharmacy - founded 1821; first school of pharmacy of USA * united stater pharmacopoeia ($usp$) - aid instablishing createdin1820 to standard for drugs in us * Pharmacopeia * Organized sets of monographs or books of unifrom drug standards. * Recipe or formula or standards required to prepare a drug * Comes from the Greek pharmakon (meaning drug) and poiein (meaning make) * British Pharmacopeia * Merging of three city pharmacopeias of London, Edinburgh, and Dublin * Established in 1864 ## A.THE UNITED STATES PHARMACOPEIA AND THE NATIONAL FORMULARY * History of the USP-NF * 1778 * Publication of the Lititz Pharmacopeia, the first American pharmacopeia * Used by the Military Hospital of the United States Army * 1808 * Publication of a 272-page pharmacopeia containing information or monographs on 536 drugs by the Massachusetts Medical Society * Included drugs indigenous to America, which were not described in the European pharmacopeias * January 6, 1817 * Lyman Spalding (Father of the United States Pharmacopeia) submitted a plan to the Medical Society of the County of new York for the creation of national pharmacopeia * January 1, 1820 * The first United States Pharmacopeial Convention assembled in Washington, D.C * Has a bord of trustees composed of eight members: two from medical sciences; two from pharmaceutical sciences; one from the public; and three from any affiliation * December 15, 1820 * Publication of the first USP in English and in Latin, with 272 pages and 217 drugs * 1888 * Publication of the first edition of the National Formulary of Unofficial Preparations by the American Pharmarceutical Association as a for of protest * 1900 * The United States Pharmacopeial Convention granted authority to issue supplements to the USP to maintain satisfactory standar ### A. USP-NF monograph * June 30, 1906 * Title of the National Formulary of Unofficial Preparations was officially changed to the National Formulary * Signing of the Pure Food and Drug Act by President Theodore Roosevelt * Designated both the USP and NF as legal standards for medicinal and pharmaceutical substances * 1940 * United States Pharmacopeial decided to revise the USP every five years while maintaining the use of periodic supplements * NF continued to be revised every ten years * 1975 * United States Pharmacopeial Convention, Inc. purchased the NF * July 1, 1980 * Publication of the first combined compedium, USP XX-NV XV * 1995 * Changing of titles from Roman numerals to Arabic numerals, USP 23-NF 18 * 2002 * USP-NF became an annual publication * Currently revised annually in hard copy and as online editions * Term "products" used for manufactured drugs; while "preparations" for compounded drugs * Has no enforcement power, but only provide standards * Chapters above are enforceable and chapters below are informational ### General Chapters of the USP-NF * Pharmaceutical Compounding - Nonsterile Preparations * Pharmaceutical Compounding - Sterile Prepararions * Hazarduus Drugs - Handling in Health Care Settings * Pharmaceutical Calculations in Pharmacy Practice * Quality Assurance in Pharmaceutical Compounding * The industrial revolution affected pharmaceutical manufacturing which adopted new machineries from other industries: * Mixers from baking industry * Centrifugal machines from the laundry industry * Sugarcoating pans from the candry industry * The industrial manufacture of chemicals also became more established, evidenced by the synthesis of compounds * Synthesis of salicylic acid created group of analgesic compounds * Sleep-producing derivatives of barbituric acid called barbiturates were also invented * arsphenamine - first synethic organic compound to be curative; treatment for syphilis discovered bu Paul Ehrlich and Sahachiro Hata. * USP-NF monograph * Standards for pharmaceutical substances that reflect the best in the current practice of medicine and pharmacy and tests and assay procedures for demonstrating compliance ### Labels of Non-compliant Substances * "adulterated" - drugs that are not of compendial strength, quality, or purity * "misbranded" - drugs not complying with compendial packaging ### Parts of a Monograph * Official title * Graphic or structural formula, empirical formula, molecular weight, and established chemical names * Chemical Abstracts Service registry number * Statement of chemical purity * Cautionary statmenet on toxicity * Packaging and storage recommendations * Chemical and physical tests * Method of assay ### C. OTHER PHARMACOPEIAS * Homeopathic Pharmacopeia of the United States * Used by pharmacists and homeopathosts to ensure the quality of homeopathic drugs * Pharmacopoeia Internationalis or International Pharmacopeia * Published by the World Health Organization of the United Nations * Intended as a recommendation to national pharmacopeial revision committees to modify their pharmacopeias according to international standards * Other countries including the United Kingdom, France, Italy, Japan, India, Mexico, Norway, and China have their own pharmacopeias. There is also a European Pharmacopeia. ### D.INTERNATIONAL ORGANIZATION FOR STANDARDIZATION * International Organization for Standardization (ISO) * International consortium of representative bodies constituted to develop and promote uniform or harmonized international standards ## IV.DRUG REGULATION AND CONTROL * Food and Drug Act of 1906 * First American law to regulate drug products manufactured domestically * Sherley Amendment of 1912 * Regulated manufacturers\` claims of therapeutic benefit. * Prohibited false claims of therapeutic effects ### A.Federal Food, Drug and Cosmetic Act of 1938 * Federal Food, Drug, and Cosmetic Act of 1938 * Prohibits the distribution and use of new drug without the prior filing of an NDA and approval of the FDA. * Enacted due to the almost 100 deaths casued by sulfanilamide ### Amendments to the Federal Food, Drug and Cosmetic Act of 1938 * Durham-Humphrey Amendment of 1951 * Established a legal distinction between prescription and OTC drugs. * Required prescription drugs to bear the subol "Rx only" * Kefauver-Harris Amendments of 1962 * Ensured a greater degree of safety for approved drugs by requiring the filing of an IND before the drug may be clinically tested on humans. * Passed due to the deaths and teratogenic effect of thalidomide ### A.Comprehensive Drug Abuse Prevention and Control Act of 1970 * Comprehensive Drug Abuse Prevention and Control Act * Also known as the Controlled Substance Act. * American law serving to consolidate and codify control authority over drugs of abuse into a single statute * Established five schedules for the classification and control of drug substances that are subject to abuse #### Table 2. Schedules of the Comprehensive Drug Abuse Prevention and Control Act of 1970 | Schedule | Medical Use | Potential for Abuse | Examples | | :------- | :---------- | :-------------------------- | :---------------------------------------------------------------------------------------------------------- | | I | none | high | Heroin, lysergic acid deithlamide, mescaline, peyote, methaqualone, marijuana | | II | | high; may lead to severe | morphine, cocanine, methamphetamine, amobarbital | | III | | less then S1 and S2;may lead to | Codeine, hydrocodone | | IV | has | less then S3;may lead to | difenoxin, diazepam, oxazepam | | V | high | Low relative | dihydrocodeine, diphenoxylate | * Comprehensive Dangerous Drugs Act of 2002 * Known as Republic Act No. 9165 * Repealed Republic Act No. 6425 or the Dangerous Drugs Act of 1972 * Had two classifications of drugs: prohibited drug and regulated drug * Law regulating dangerous drugs, controlled precursons, and essential chemicals in the Philippines ### B. FDA PREGNANCY CATEGORIES * FDA pregnancy categories * Categories assisting in appropriate prescribing and the risk-versus-benefit assessment of the medication for a specific patient * Used to estimate the potential of a systematically absorbhed drug for causing birth defects ### Table 3. FDA Pregnancy Categories | Category | Risk in Animal Studies | Risk in Human Studies | Overall Risk | | :------- | :-------------------------- | :--------------------- | :--------------------------------------------- | | A | multiple Vitamins | No evidence to risks | NO evidence of risks | | B | No of risks | No evidence to risks | No of risks | | C | evidence of adverse effects | No adequate | Potential benefits should be used despite risk | | D | Positive evidence to risks | No adequate | Potential benefits should be used despite risk | | E | evidence to risks | evidence to risks | Risks overweight potential benefits | C. MEDICATION EXPOSURES DURING PREGNANCY AND LACTATION * Every woman in the general population has a 3% to 5% risk of havinga child with a birth defect or mental retardation. * Pregnant or breast-feeding patients taking or considering taking a medication needs to be counseled about potiental adverse effects on the fetus or infant. * Teratogen * Substances that may produce physical or functional defects in the human embryo or fetus on exposed pregnant ### Factors to Conseder Assessment Teratogenic * Potential of a * Stage of pregnancy at which that exposure occurred amount of medication taken ### D. BLACK BOX WARNING * Areas * Situaition Using Black Box * There is an reverse reaction so serious in position to the potential benefit that it be considered in assessing the risks and benefits of using the drug Risk to severity careful use the of the severity FDA has approved the drug to prescribing of to ensure safe its use Drug that severe reaction can and be or can bevents or use restriction * Listwing * FDA has approval has restrictions ### E.DRUG LISTING ACT OF 1972 * Drug Listing Act of 1972 * Provided FDA with authoriting to complex list of marketed drugs to assert in crackdown of unsafe, ineffective, adulterated, and mislabeled drugs ## F.ORPHAN DRUG ACT OF 1983 * Orphan Drug Act of 1983 *Provides tax credits and designated years of to companirs who on to or tax credits designated or on. ### Drug Orphan has which is to cover costs research and drugs from the product PHA 619 LEC Introductto Drugs and Pharmacy5 of 6 * orphan disease * Rare disease * rare disease or * affect fewer than 200.000 people (ej. chronic * lympocytic leukemia, Gaucher disease, cystic fibrosis, AIDS) ### C. OF * Drug Price and Patent Restoration Drug Price and Patent Restoration Act of 1984 * Allows Filing Actgeneric copies * Extended patent for to NDA half * Provided for with the of H. Act OF * Marketing Amandment 1987 * Prohibitions or the 1987 ### 1.ACT OF 1992 ### Dietary Supplement Health and ### Education Act of 1994