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Introduction to Drugs and Pharmacy

• A drug is an agent intended for the diagnosis, mitigation, treatment, cure, or prevention of disease in humans or animals.
• A drug may be recognized in the USP-NF, the Homeopathic Pharmacopeia of the United States, or the British Pharmacopeia.
• Drugs have diverse actions and effects, such as mydriatics which dilate the pupil and miotics which constrict it.
• A new drug can be derived from plant or animal sources, microbial growth by-products, or through chemical synthesis, molecular modification, or biotechnology.

Pharmaceutics

• Pharmaceutics is a branch of pharmaceutical sciences dealing with turning new chemical entities into dosage forms.
• Activities in this field include:
  • Investigating physical and chemical properties of drug molecules.
  • Designing, fabricating, and evaluating drug delivery systems.
  • Monitoring absorption, distribution, metabolism, and excretion (ADME) of drug products.
  • Dosage forms deals with the formulation of active substances in combination with other drugs to produce a desirable dosage form.
  • Physical pharmacy deals with the physicochemical principles underlying dosage form design and development.
  • Pharmaceutical manufacturing is the process of making drugs from raw materials into finished products on an industrial scale, based on Current Good Manufacturing Practice.
  • Pharmaceutical technology involves converting an active component into a drug product.

Technologies

• First technology - process; creation of a technology to produce an active compound with good quality and in large quantity.
• Second technology – formulation; drug manufacturing preparation from raw material until the final product with an optimal result.
• Third technology - analytical and quality evaluation; ensuring the quality of the final drug product until it is used by the patient.

Heritage of Pharmacy

• Drugs in the form of vegetation and minerals have existed as long as humans.
• Diseases were believed to have been caused by demons or spirits.
• Ancient remedies involved spiritual aspects and herbal applications.

First Apothecary

• An apothecary prepares and sells drugs for medicinal purposes.
• Apothecaries were originally associated with the mysterious, eventually merging with duties of priests.

Pharmacy

• Pharmacy comes from the Greek word "pharmakon," meaning a charm or a drug
• Pharmacy relates to preparing and dispensing medication
• Pharmacy provides drug-related information to the public and involves prescription interpretation.

Early Drugs

• Sumerian clay tablets dating back to 3000 BC contain the world's oldest written prescriptions.
• The Ebers Papyrus, discovered by Georg Ebers, is a continuous scroll with over 800 formulas, listing more than 700 drugs.

Introduction of the Scientific Viewpoint

• Hippocrates: Greek physician, known as the Father of Medicine, introduced scientific pharmacy and medicine; his teachings are embodied in the Hippocratic oath.
• Dioscorides: Greek physician and botanist, wrote De Materia Medica, an early milestone on medicinal materials.
• Pharmacognosy: the study of natural product drug chemistry, from the words pharmakon and gnosis.
• Claudius Galen: Greek pharmacist-physician, credited with creating 500 treatises on medicine and developed preparations known as Galenic pharmacy, including Galen's cerate.
• Emperor Frederick II of Germany: Created a decree that separated pharmacy and medicine in 1240 AD.
• Aureolus Theophrastus Bombastus von Hohenheim: Swiss physician who called himself Paracelsus, known as the Father of Toxicology, transformed pharmacy from botany to chemistry.

Early Research

• Karl Wilhelm Scheele : Discovered lactic, citric, oxalic, tartaric, and arsenic acid, glycerin.
• Scheele also invented new methods for preparing calomel and benzoic acid and discovered oxygen.
• Famous Pharmacists Across History:
  • Friedrich Sertürner – isolated morphine from opium
  • Joseph Caventou and Joseph Pelletier - discovered quinine, cinchonin, strychnine, and brucine
  • Pierre Robiquet and Pelletier discovered caffeine

Schools of Pharmacy

• Royal College of Apothecaries: founded in 1441 and the oldest college of pharmacy.
• Philadelphia College of Pharmacy: founded in 1821 and the first school of pharmacy in the USA
• United States Pharmacopeia (USP): created in 1820 to standardise drugs in US and aid in establishing in standard

Drug Standards

• Pharmacopeia: Organized sets of monographs or books of uniform drug standards that provide recipes or formulas to prepare drugs, deriving from the Greek words pharmakon and poiein.
• British Pharmacopeia: Merging of three city pharmacopeias of London, Edinburgh, and Dublin, established in 1864.

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 the first 272-page pharmacopeia containing monographs on 536 drugs by the Massachusetts Medical Society, including drugs indigenous to America.
  • January 6, 1817: Lyman Spalding submitted a plan to the Medical Society for the creation of national pharmacopeia.
  • January 1, 1820: Assembling of the first United States Pharmacopeial Convention in Washington, D.C., with a board of trustees.
  • 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 Pharmaceutical Association as a protest.
  • 1900: The United States Pharmacopeial Convention granted authority to issue supplements to the USP to maintain standards.
  • June 30, 1906: Signing of the Pure Food and Drug Act by President Theodore Roosevelt, designating the USP and NF as legal standards
  • 1940: United States Pharmacopeial decided to revise the USP every five years
  • 1975: United States Pharmacopeial Convention, Inc., purchased the NF
  • July 1, 1980: Publication of the first combined compendium, USP XX-NF XV.
  • 1995: Changing of titles from Roman numerals to Arabic numerals, USP 23-NF 18
  • 2002: USP-NF became an annual publication, revised yearly, using the term "products" for manufactured drugs and "preparations" for compounded drugs, with limited enforcement power

USP-NF Chapters

• <795> Pharmaceutical Compounding - Nonsterile Preparations
• <797> Pharmaceutical Compounding - Sterile Preparations
• <800> Handling Hazardous Drugs in Health Care Settings
• <1160> Pharmaceutical Calculations in Pharmacy Practice
• <1163> Quality Assurance in Pharmaceutical Compounding
• The industrial revolution affected pharmaceutical manufacturing which adopted new machineries from other industries.
• The industrial manufacture of chemicals also became more established

USP and NF Monographs

• Standards for reflecting current medical practices and testing procedures.

Labels of Non-compliant Substances

• "adulterated" - drugs that are not of compendial strength, quality, or purity
• "misbranded" - drugs not complying with packaging and labeling standards

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

Other Pharmacopeias

• Homeopathic Pharmacopeia of the United States
• Pharmacopoeia Internationalis or International Pharmacopeia: Published by the World Health Organization of the United Nations
• Other countries possessing: United Kingdom, France, Italy, Japan, India, Mexico, Norway, and China.

International Organization for Standardization (ISO)

• A consortium of bodies to develop and promote uniform international standards.

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 and claims.
• Federal Food, Drug, and Cosmetic Act of 1938: Prohibits the distribution and use of new drug without filing an NDA and approval of the FDA.
• Durham-Humphrey Amendment of 1951: Established a legal distinction between prescription and OTC drugs; required prescription drugs to bear the symbol "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.
• Comprehensive Drug Abuse Prevention and Control Act of 1970: Also known as the Controlled Substances Act; established five schedules for drug classification.
• Comprehensive Dangerous Drugs Act of 2002.

FDA Pregnancy Categories

• A: No risk in animal and human studies
• B: Evidence of no human risk, but possible animal risk.
• C: Risk cannot be ruled out
• D: Positive evidence of risk
• E: Contraindicated in pregnancy

Medication Exposures During Pregnancy and Lactation

• 3% to 5% risk of birth defect or retardation in any pregnancy.
• Pregnant patients should be counseled regarding medication effects.

Situations Using Black Box Warnings

• Risk of a serious adverse reaction.
• FDA approval with use restrictions.

Drug Listing Act of 1972

• Gave FDA authority to manage and list marketed drugs.
• Required listing information from manufacturers and distributors.

Orphan Drug Act of 1983

• Provides incentives to develop drugs for rare diseases, which are conditions that affect less 200,000 people.

Drug Price Competition and Patent Term Restoration Act of 1984

• Facilitated generic drug approval process
• Extended patent protection.

Prescription Drug Marketing Act of 1987

• Safeguard the integrity of supply of prescription drugs.
• Allows the FDA to accept fees from drug reviews.

Dietary Supplement Health and Education Act of 1994

• Regulate labeling for dietary supplements
• Claim labels cannot prevent or cure disease

Food and Drug Association Modernization Act of 1997

• Protect public health against risks associated with all products.

Biologics Price Competition and Modernization Act of 2009

• Accelerated approval pathway for biologic drugs.

Drug Quality and Security Act of 2013

• Compounded products are exempted from drug requirements.

Drug Product Recall

• A manufacturer action to return a marketed product that can present a threat to consumer safety
• Three types of recalls:
  • Class I Recalls: For products with a high probability of causing serious or adverse health consequences or death
  • Class II Recalls: For products that may cause temporary or medically reversible adverse health consequences or have remote probability of harm
  • Class III Recalls: For products that are not likely to cause adverse health consequences

New Drug Development and Approval Process

• Scientific discoveries and technological advancements of new drug mechanisms will lead to new drugs

Drug Substance

• An active ingredient or component that creates a pharmacologic activity
• Can be produced by multiple ways
• It Needs appropriate purification

New Chemical Entity

• A drug with unknown clinical, toxicologic, physical, and chemical properties

Drug Product

• The finished product that is a combination of the Drug and other excipients or inert substances

New Drug Sources

• Natural: use of plant and their conversion to botanic folklore
• Synthetic: Altering the nucleus and/or structure
• Animal: used to produce products such as vaccines

Rapid Drug Process triggers

• Discover of new drugs and their commericialization
• Worldwide generation of scientific and biomedical institution
• Upsurge in production during World War II

Human Gene Therapy

• Modifying of the genetic material of living cells
• Was first used to treat adenosine deaminase deficiency

Goal Drug

• theoretical drug that would produce desires result with minimal dose

Method of Drug Discovery

• Using screening, molecular modification, design and research

General Drug Naming

• Usefulness to health practitioners
• Single word name
• No conflicting names and not non-proprietary
• Distinctive terminalogy for specific drugs and groups

Empirical Formula

• The number and relationship of atoms in the molecules

Pharmacology

• The science concerned drugs, their sources, appearance,chemistry,actions, and uses

Subdivision of pharmacology

• Pharmacokinetics the studies what body effect has on drugs pharmacodynamics studies how the drug impacts the body

Common Disease

• Most new durgs have been created to identify a cause and a process
• This process can interfere with said disease

Toxicology

• The study of deals with adverse effects of durgs

Early Fomulation Studies

• Studies of the different intrinsic and physical properties of drug

Pre-ind Meeting

• Providing advice of scientific, technical, and formating contents relating the the ind

Clinical Protocol

• Provide the appropriate design

Phases of clinical studies

• Phases 1: Saftey and early stage clinical pharmacology. 20 to 100 patients.
• • Phases 2:Initial saftey and efficancy several hundred patients
• phases 3. Comprehensivr safe and efficacy hundred thousands patients
• Phase 4 : Studies postmarking
• --- testing ,continual test

Control in Clinical study

• Positive control standard drug
• negative control placebo.

Phase 3 studies

• studies is complete for nda studies
• studies is continue

Usual adult doors

• amount with with is the will of a desired results
• starting of doctors

types of minimum concentration

• minimum effector

Minimum effector concentration mdc

• avergae blood serum concentration to for the drug
• minimun toxicity of concentration
• less of drug

type of medium doors

• the effects amount that produce intensity factors of considering.
• Age,weight,sex,
• drug: Ability during the influence.

Withdraw or terminant

• end and investigation will be withdrawn.

Food and Administration:

• safe for consumptions for new drug.

Routes of drug and administration:

• permints of patient who has threatning of a severe disease.

Drug Product Labling

• not only must also be -package inserts
• company literatures

Supplimental:

• Drug application change can be for more better and
• --- improved to the fda

Abbreviated new drug Application

• Approval for marketing

• The Chemistry Documentions

• Current Good Manufacturing Practices*

• Established to make sure minimal standards

• Apply to forieg and domestic suppliers

• Tamper- evident packaging*

• One or MORE barriers to Entry

• Container* holds medication or is In direct contact with the article and must be

• --physically and/or chemically ___interaction

• Immediate container:Direct contact with the article every

• testing containers*

• Classifications*

• welled closed

• tight containers= Protect from the loss of

• -Article and from efflorscence etc.

• hertmatic container :

• --Resistant to any any the gas.

Types of Continers

• singled DOS-s contain. =Quantity meant for and single —-Dose

Multi-unit Container=

• allows with Draw portions the contact
• --with Danger the quality

Singled VS multiple

• unit containers:Designed to holds a drug for admin
• -with the convenint

Advantages =positive ID + med error Reductions === Reduceding of dispension time etc. Multiple

• unit containers:

Light resistant Container

• PROTEC pharm.From photo chemical dteration
• can Be Ambered and must meet u.s.p
• standards
• Plastic packaging*
• light weight an 1 mpact. reduction
• Alteration propertys on Storage*
• Addition the plasticizes Etc with.
• -----Drug subjections to greater oxidation compared
• Child. resistant Contarers*
• protector. Againt unreasonable. risks assoical with injuries
• Exepmtions child- resistant containers*
• prescriptions/ patients REQuestions otherwise.
• Compliances*
• used to assit patient is making. Meds on schedules Facilitating patient.
• Multiple medicatoins

OTC / DRug Over-the-counter LABEL.

• dietary Supplments* Must contain: "supped. Fact panel" which contains:
• idenity and quantity
• nutriton values
• and adress
• Effects of freezing Product*
• .risk brakeage ++LOSS Stength ++ Aleration the dosage etc

Dosage Form Design** Pharmutacetical ingredient or excipients non- Medical ingredients to used multiple types

• Acidity agents provides. acidic medium or stability: Acetic acid,* Etc

• Bulffring Agent RESITS change* +++ upon Dilutions

• *FlavorANT imparts and Pleasant fav and often door:**.

• Anisole*, Cocoa

• --Preservative/ SOLVER ,

• Stabilizers*

• ANTDEXIDANTS OR CHEALETING agents SWEETNER*

• -LEVIGATING AgENTE

• Solid preparation

• Anti-adherent/ Binder etc

• Route of Drug administeration*

• Drugs may be administered in many ways.

• chosen To depends the wased effect.

• local effect*- achive a site

• Intravenous and buccel forms a prescent.

• extemeity rapidity on-Set of actions.

ORal Route.

=Most frquent route ===easy and convenient, but ==indudes drugs absorption

• Dosage Applicatbol for ORute*.

• Tablets

• capsules

• sustained release

• solution/

• suspension

• Dosagr forms Reectale route* += Suppository

• --solid Bodies v shape and wegit

• Recal ointment /Solution=

• parnetal rout*

• -Derive from words

• Administratio. to of hollow fine and need for the sites body and epts*.

• can NOT be removed once asminstirated*.

• dosage appicable for the parnetial*

• sterile solution/ act MORE rapify

• --sterlie susppenison:slowly/ absorbs ===Achoved through