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Lecture # 01
Introduction to Pharmacy
Pakistan Pharma Career Door is thankful to Madam Kashifa Khanam for giving her
precious time. She is currently affiliated with Hilton Pharmaceuticals and serving
as Manager Quality Assurance. She completed her Bachelors in Pharmacy and then
thirst for knowledge lead her to completion of her Masters in Business
Administration (MBA). When she came to know about the mission and vision of
Pakistan Pharma Career Door, she showed her will to join as facilitator. Hope you
will all enjoy the slides.
Feel free to ask any question relating to course at numbers provided you to.
Best of Luck!
Muhammad Saquib Qureshi
Pakistan Pharma Career Door
INTRODUCTION TO
PHARMACY &
PHARMACEUTICS
KASHIFA KHANUM
B. PHARM, MBA
WHAT IS PHARMACY?
 PHARMACY DERIVED FROM WORD
“PHARMAKON” MEANS MEDICINE OR
DRUG
 IT’S GREEK WORD
 PHARMACY IS;
 ART OF DISPENSING AND PRE
PREPARING OF MEDICINE OR DRUGS
 ESTABLISHMENT AND PLACE WHERE
DRUGS OR MEDICINE ARE SOLD.
THE WORD PHARMACY HAS TWO
MEANINGS;
• GENERAL SENSE
• IT IS A PLACE WHERE MEDICINE
OR DRUGS ARE SOLD
• PROFESSIONAL SENSE
• IT IS THE PROFESSION, MEMBER
OF WHICH DEALS WITH
MEDICINE OR DRUGS
PHARMACY
 PHARMACY IS ART & SCIENCE OF PREPARATING
MEDICATION AND PROVISION OF PROVIDING
INFORMATION RELATED TO DRUG TO PUBLIC.
 PHARMACY IS THE STUDY OF SCEINCE OF DRUGS;
 WHERE THE COME FROM? - ORIGIN OF DRUG
 HOW THEY ACT ON THE BODY? - MODE OF
ACTION
 HOW TO DRUG TURN INTO MEDICINE? -
PHARMACEUTICS
DIFFERENCE IN
DRUG &
MEDICINE
DIFFERENCE IN DRUG & MEDICINE
DRUG
 A DRUG IS ANY SUBSTANCE THAT
ACT ONLIVING BODY TO ALTER THE
PHYSIOLOGICAL PROCESS, AND ARE
USE FOR THE PREVENTION,
DIAGNOSIS AND TREATMENT OF
DISEASE.
MEDICINE
 A MEDICINE IS ANY DRUG WHICH
HAS A DEFINITE FORM & DOSE AND
ARE THERAPEUTICALLY USED FOR
THE TREATMENT OF DISEASE OF
LIVING OBJECTS.
PHARMACIST
 ALSO KNOWN AS DRUGGIST OR
CHEMIST, ARE HEALTHCARE
PROFESSIONALS WHO PRACTICE IN
PHARMACY, THE FIELD OF HEALTH
SCIENCES FOCUSING ON SAFE AND
EFFECTIVE MEDICATION USE
REASONS TO CHOOSE PHARMACY AS
PROFESSION
 I WANT A DYNAMIC, PEOPLE ORIENTED CAREER IN HEALTHCARE.
 I WANT DIVERSE EMPLOTEMENT OPPORTUNITIES.
 I WANT A FLEXIBLE WORK ENVIRONMENT.
 I WANT A CONFORTABLE INCOME.
 I WANT TO BE A PART OF A RESPECTEDD PROFESSION.
COMMON SYMBOLS USED IN PHARMACY
BOWL OF HYGEIA
 THE BOWL WITH SNAKE COILED
AROUND, IT IS CALLED THE BOWL
OF HYGIEA WITH THE SERPENT OF
EPIDAURUS.
 HYGEIA WAS AESCULAPIUS’S
DAUGHTER AND A GREEK GODDESS
OF HEALTH
 HER SYMBOL WAS SERPENT
DRINKING FROM A BOWL.
CADUCEUS
 THE SYMBOL OF TWO SNAKES ON A
STAFF IS CALLED CADUCEUS.
 THE STAFF DEPICTED WITH WINGS, IS
THAT OF MERCURY (ROMAN) OR
HEMES (GREEK), MESSENGER OF THE
GOD AND ALSO GOD OF COMMERCE.
 THE GREEK ROOT OF THE WORD
CADUCEUS MEANS “HERALD’S WAND”.
MORTAR & PESTLE
 THE MORTAR & PESTLE HAS BEEN
USED SINCE LONG AS A
PHARMACEUTICALS SYMBOLS IN
BRITAIN AND ON THE EURPEAN
MAINLAND, AND STILL WIDELY
EMPLOYED AS A PHARMACY SHOP
SIGN IN SCOTLAND.
 THE MORTAR & PESTLE ARE TOOLS OF
TRADDITIONAL PHARMACY, HENCE
THEIR USE AS AN EASILY
RECOGNIZEABLE VISUAL MOTIF.
RECIPE
 THE RECIPE SIGN APPEARS AT THE
START OF PRESCRIPTIONS.
 ALTHOUGH UNIVERSALLY ACCEPTED
AS AN ABBREVIATION OF “RECIPE”.
 LATIN FOR TAKE THOU
 IT HAS ALSO BEEN SUGGESTEDD
THAT IT IS THE ASTRONOMICAL
SIGN OF THE PLANET JUPITER.
PHARMACEUTICS
 THE STUDY OF INTERFERANCE
BETWEEN DRUG/MEDICINE AND
BODY.
 THE ART ND APPLIED SCIENCE OF
DOSAGE FROM DESIGN.
 DEALS WITH MANY ASPECTS OF
INTERACTION BOTH INSIDE (INVIVO)
AND OUT SIDE (IN VITRO) BODY.
OBJECTIVE OF PHARMACEUTICS
 TO DESIGN AND IMPLEMENT A DOSAGE
FORM THAT IS BOTH SAFE AND EFFECTIVE
FOR THE DRUG’S INTENDED USE!
A BROAD FIELD THAT DRAWS FROM MANY
DISCIPLINES
 PHYSICAL CHEMISTRY (ORGANIC AND INORGANIC)
 MEDICINAL CHEMISTRY
 ANATOMY, PHYSIOLOGY
 MICROBIOLOGY
 ATOMIC PHYSICS
 ENGINEERING (CHEMICAL, MATERIAL)
PHARMACODYNAMICS
SITE/MECHANISM OF ACTION, POTENCY,
EFFICACY, ETC
PHARMACOKINETICS
absorption, distribution, metabolism, excretion
PHARMACOKIENETICS
 PHARMACOKINETICS DESCRIBED AS WHAT THE BODY DOES TO A DRUG, REFERS
TO THE MOVEMENT OF DRUG INTO, THROUGH, AND OUT OF THE BODY;
 ABSORPTION
 DISTRIBUTION
 ELIMINATION
PHARMACOKIENETICS MODEL
 ONE OF THE PRIMARY OBJECTIVES OF PHARMACOKINETIC MODELS IS TO
DEVELOP A QUANTITATIVE METHOD TO DESCRIBE THE RELATIONSHIP OF DRUG
CONCENTRATION, OR AMOUNT IN THE BODY, AS A FUNCTION OF TIME.
USES OF PHARMACOKIENETIC NODEL
 THERE ARE A WIDE VARIETY OF POTENTIAL USES FOR PHARMACOKINETIC
MODELS, WHICH INCLUDE:
 1. PREDICTION OF DRUG CONCENTRATION IN BLOOD/PLASMA OR TISSUE.
 2. CALCULATION OF A DOSAGE REGIMEN.
 3. QUANTITATIVE ASSESSMENT OF THE EFFECT OF DISEASE ON DRUG
DISPOSITION.
 4. ELUCIDATION OF THE MECHANISM OF DISEASE-INDUCED ALTERATIONS IN
DRUG DISPOSITION.
 5. DETERMINATION OF THE MECHANISM FOR DRUG–DRUG INTERACTIONS.
 6. PREDICTION OF DRUG CONCENTRATION VERSUS EFFECT RELATIONSHIPS.
TYPES OF PHARMACOKIENETICS MODELS
 THERE ARE THREE PRIMARY TYPES OF PHARMACOKINETIC MODELS:
 COMPARTMENTAL,
 NON COMPARTMENTAL, AND
 PHYSIOLOGICAL.
PHARMACODYNAMICS
 PHARMACODYNAMICS IS THE STUDY OF THE BIOCHEMICAL AND
PHYSIOLOGICAL EFFECTS OF DRUGS ON THE BODY OR ON MICROORGANISMS OR
PARASITES WITHIN OR ON THE BODY AND THE MECHANISMS OF DRUG ACTION
AND THE RELATIONSHIP BETWEEN DRUG CONCENTRATION AND EFFECT
DIFFERENCE IN PHARMACODYNAMICS &
PHARMACOKIENETICS
 PHARMACODYNAMICS IS OFTEN SUMMARIZED AS THE STUDY OF WHAT A DRUG
DOES TO THE BODY, WHEREAS PHARMACOKINETICS IS THE STUDY OF WHAT
THE BODY DOES TO A DRUG. PHARMACODYNAMICS IS SOMETIMES ABBREVIATED
AS "PD", WHILE PHARMACOKINETICS CAN BE REFERRED TO AS "PK".
DOSAGE FORM DESIGN
STORAGE
 RATE OF DEGRADATION
(EXPIRY)
 LIQUID/SOLID?
 WHAT CONDITIONS?
 TEMPERATURE
 HUMIDITY
 WHAT CONTAINER
 HOW INERT IS IT? WHAT IS
THE RISK FOR
CONTAMINATION?
COMPATIBILITY
 ACTIVE VS. ACTIVE VS.
“INERT” INGREDIENTS
 CONTAINER (AGAIN)
DOSAGE FORM DESIGN
ORGANOLEPTIC
CONSIDERATIONS
 PHYSICAL APPEARANCE,
TASTE, SMELL, TACTILITY,
SIZE
 “PHARMACEUTICAL
ELEGANCE”
MANUFACTURING
 FOR A POWDER, HOW WELL
DOES IT FLOW?
WHAT YOU MUST KNOW TO DESIGN A
DOSAGE FORM
 PHYSICOCHEMICAL PROPERTIES OF THE
DRUG
 REACTIVITY, STABILITY
 SOLUBILITY, ACID/BASE, SOLID STATE
BEHAVIOR
 BIOPHARMACEUTICAL CONSIDERATIONS
 WHAT IS THE INTENDED SITE OF ACTION?
 SYSTEMIC? TOPICAL?
 WHERE/HOW WELL IS THE DRUG
ABSORBED?
 WHAT IS THE INTENDED ONSET OF
ACTION?
 IMMEDIATE-RELEASE, SUSTAINED-
RELEASE, PULSE RELEASES
DOSAGE FROMS
 SOLID DOSAGE FORMS
 POWDERS
 TABLETS
 CAPSULES (HARD, SOFT)
 SUPPOSITORIES*
 OINTMENT, CREAM, GEL, ETC.*
 AEROSOL
 LOZENGE
 CIGARETTE
 LIQUID DOSAGE FORMS
 SOLUTIONS
 SUSPENSIONS
 (GAS)
DOSAGE FORM
POWDER
 WHEN THE TERM ‘‘POWDER’’ IS
REFERRED TO AS A DOSAGE FORM,
IT REPRESENTS A FORMULATION
THAT IS A MIXTURE OF POWDERED
DRUG AND EXCIPIENTS.
TABLETS
 ACCORDING TO THE USP, TABLETS ARE
SOLID DOSAGE FORMS, CONTAINING
MEDICINAL SUBSTANCES WITH OR
WITHOUT SUITABLE DILUENTS. THEY
MAY BE CLASSED, ACCORDING TO THE
METHOD OF MANUFACTURE, AS
COMPRESSED TABLETS OR MOLDED
TABLETS.
DOSAGE FORM
CAPSULES
 CAPSULES ARE SOLID DOSAGE
FORMS IN WHICH THE DRUG
SUBSTANCE IS ENCLOSED IN EITHER
A HARD OR SOFT, SOLUBLE
CONTAINER OR SHELL OF A
SUITABLE FORM OF GELATIN.
SUPPOSITORIES
 A SUPPOSITORY IS A DRUG
DELIVERY SYSTEM THAT IS INSERTED
INTO THE RECTUM (RECTAL
SUPPOSITORY), VAGINA (VAGINAL
SUPPOSITORY) OR URETHRA
(URETHRAL SUPPOSITORY), WHERE
IT DISSOLVES OR MELTS AND IS
ABSORBED INTO THE BLOOD
STREAM. THEY ARE USED TO
DELIVER BOTH SYSTEMICALLY AND
LOCALLY ACTING MEDICATIONS.
DOSAGE FORM
TOPICAL
(OINTMENT, CREAM, GEL, ETC.)
 MEDICATIONS ARE APPLIED TO THE
SKIN OR ITS APPENDAGES OR
INSERTED INTO BODY ORIfiCES IN
LIQUID, SEMISOLID, OR SOLID
FORM.
AEROSOLE
 THE TERM AEROSOL IS USED TO
DENOTE VARIOUS SYSTEMS
RANGING FROM THOSE OF A
COLLOIDAL NATURE TO SYSTEMS
CONSISTING OF PRESSURIZED
PACKAGES. AEROSOLS HAVE BEEN
DEfiNED AS COLLOIDAL SYSTEMS
CONSISTING OF VERY fiNELY
SUBDIVIDED LIQUID OR SOLID
PARTICLES, DISPERSED IN AND
SURROUNDED BY A GAS.
DOSAGE FORM
 LIQUID DOSAGE FORM (SOLUTION, SUSPENSION, EMULSION)
 THESE DOSAGE FORMS ARE PREPARED BY EMPLOYING PHARMACEUTICALLY AND
THERAPEUTICALLY ACCEPTABLE VEHICLES. THE ACTIVE INGREDIENT(S) MAY BE
DISSOLVED IN AQUEOUS MEDIA, AN ORGANIC SOLVENT, OR A COMBINATION OF
THE TWO, BY SUSPENDING THE DRUG (IF IT IS INSOLUBLE) IN AN APPROPRIATE
MEDIUM OR BY INCORPORATING THE ACTIVE PHARMACEUTICAL INGREDIENT
INTO ONE OF THE PHASES OF AN OIL AND WATER EMULSION.
DOSAGE FROM
 LIGHT
 UV
  RAYS
ROUTES OF ADMINISTRATION
 ORAL
 PARENTERAL
 IV, IM, SC, ETC.
 OPHTHALMIC, OTIC
 NASAL
 RECTAL, VAGINAL, URETHRAL
 BUCCAL
 TOPICAL
ANALYSIS OF PHARMACEUTICL PRODUCTS
 THE PHARMACEUTICAL MANUFACTURER IS RESPONSIBLE FOR ENSURING THE
QUALITY, PURITY, IDENTITY, AND STRENGTH OF EACH LOT OF DRUG PRODUCT
MANUFACTURED. ONE MANDATORY CONTROL STRATEGY IS TO ENSURE THAT
THE LOT ‘‘CONFORMS TO SPECIfiCATION,’’ WHICH MEANS THAT THE DRUG
PRODUCT (FORMULATED PREPARATION), WHEN TESTED TO THE LISTED
ANALYTICAL PROCEDURES, WILL MEET THE LISTED ACCEPTANCE CRITERIA.1
SPECIfiCATIONS ARE CRITICAL QUALITY STANDARDS.
QUALITY ASSURANCE & QUALITY
CONTROL IN PHARMA INDUSTRY
 INDUSTRY,TO ENSURE COMPLIANCE WITH THESE GOVERNMENT REGULATIONS
AND WITH THEIR OWN INTERNAL POLICIES AND PROCEDURES, HAS DEVELOPED
VERY SOPHISTICATED QUALITY ORGANIZATIONS WITH WELL-DEFINED
RESPONSIBILITIES.
 IT HAS BEEN ACCEPTED THAT QA AND QC HAVE DIFFERENT FUNCTIONS WITHIN
AN ORGANIZATION; ALTHOUGH BOTH ARE CONSIDERED PART OF THE QUALITY
UNIT AS IDENTIFIED IN THE CODE OF FEDERAL REGULATIONS TITLE 21 (CFR)
QUALITY ASSURANCE & QUALITY
CONTROL IN PHARMA INDUSTRY
 QC MOST COMMONLY FUNCTIONS TO TEST AND MEASURE MATERIAL AND
PRODUCT.
 QA ESTABLISHES SYSTEMS FOR ENSURING THE QUALITY OF THE PRODUCT.
FIRMS MUST DECIDE UPON THE EXACT ROLES THEY WISH QC AND QA TO
PERFORM IN OPERATIONS AND PUT THESE DEFINITIONS IN WRITING.
OBJECTIVE OF THIS COURSE
KNOWLEDGE SHARING
OVERVIEW OF BASICS OF PHARMACY
ASK QUESTION
REFERENCE
 REMINGTON – AN INTRODUCTION TO PHARMACY
 http://www.msdmanuals.com/professional/clinical-
pharmacology/pharmacokinetics/overview-of-pharmacokinetics
 21 CFR

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Lecture01introductiontopharmacy 151120164739-lva1-app6891

  • 1.
  • 2. Lecture # 01 Introduction to Pharmacy Pakistan Pharma Career Door is thankful to Madam Kashifa Khanam for giving her precious time. She is currently affiliated with Hilton Pharmaceuticals and serving as Manager Quality Assurance. She completed her Bachelors in Pharmacy and then thirst for knowledge lead her to completion of her Masters in Business Administration (MBA). When she came to know about the mission and vision of Pakistan Pharma Career Door, she showed her will to join as facilitator. Hope you will all enjoy the slides. Feel free to ask any question relating to course at numbers provided you to. Best of Luck! Muhammad Saquib Qureshi Pakistan Pharma Career Door
  • 4. WHAT IS PHARMACY?  PHARMACY DERIVED FROM WORD “PHARMAKON” MEANS MEDICINE OR DRUG  IT’S GREEK WORD  PHARMACY IS;  ART OF DISPENSING AND PRE PREPARING OF MEDICINE OR DRUGS  ESTABLISHMENT AND PLACE WHERE DRUGS OR MEDICINE ARE SOLD.
  • 5. THE WORD PHARMACY HAS TWO MEANINGS; • GENERAL SENSE • IT IS A PLACE WHERE MEDICINE OR DRUGS ARE SOLD • PROFESSIONAL SENSE • IT IS THE PROFESSION, MEMBER OF WHICH DEALS WITH MEDICINE OR DRUGS
  • 6. PHARMACY  PHARMACY IS ART & SCIENCE OF PREPARATING MEDICATION AND PROVISION OF PROVIDING INFORMATION RELATED TO DRUG TO PUBLIC.  PHARMACY IS THE STUDY OF SCEINCE OF DRUGS;  WHERE THE COME FROM? - ORIGIN OF DRUG  HOW THEY ACT ON THE BODY? - MODE OF ACTION  HOW TO DRUG TURN INTO MEDICINE? - PHARMACEUTICS
  • 8. DIFFERENCE IN DRUG & MEDICINE DRUG  A DRUG IS ANY SUBSTANCE THAT ACT ONLIVING BODY TO ALTER THE PHYSIOLOGICAL PROCESS, AND ARE USE FOR THE PREVENTION, DIAGNOSIS AND TREATMENT OF DISEASE. MEDICINE  A MEDICINE IS ANY DRUG WHICH HAS A DEFINITE FORM & DOSE AND ARE THERAPEUTICALLY USED FOR THE TREATMENT OF DISEASE OF LIVING OBJECTS.
  • 9. PHARMACIST  ALSO KNOWN AS DRUGGIST OR CHEMIST, ARE HEALTHCARE PROFESSIONALS WHO PRACTICE IN PHARMACY, THE FIELD OF HEALTH SCIENCES FOCUSING ON SAFE AND EFFECTIVE MEDICATION USE
  • 10. REASONS TO CHOOSE PHARMACY AS PROFESSION  I WANT A DYNAMIC, PEOPLE ORIENTED CAREER IN HEALTHCARE.  I WANT DIVERSE EMPLOTEMENT OPPORTUNITIES.  I WANT A FLEXIBLE WORK ENVIRONMENT.  I WANT A CONFORTABLE INCOME.  I WANT TO BE A PART OF A RESPECTEDD PROFESSION.
  • 11. COMMON SYMBOLS USED IN PHARMACY
  • 12. BOWL OF HYGEIA  THE BOWL WITH SNAKE COILED AROUND, IT IS CALLED THE BOWL OF HYGIEA WITH THE SERPENT OF EPIDAURUS.  HYGEIA WAS AESCULAPIUS’S DAUGHTER AND A GREEK GODDESS OF HEALTH  HER SYMBOL WAS SERPENT DRINKING FROM A BOWL.
  • 13. CADUCEUS  THE SYMBOL OF TWO SNAKES ON A STAFF IS CALLED CADUCEUS.  THE STAFF DEPICTED WITH WINGS, IS THAT OF MERCURY (ROMAN) OR HEMES (GREEK), MESSENGER OF THE GOD AND ALSO GOD OF COMMERCE.  THE GREEK ROOT OF THE WORD CADUCEUS MEANS “HERALD’S WAND”.
  • 14. MORTAR & PESTLE  THE MORTAR & PESTLE HAS BEEN USED SINCE LONG AS A PHARMACEUTICALS SYMBOLS IN BRITAIN AND ON THE EURPEAN MAINLAND, AND STILL WIDELY EMPLOYED AS A PHARMACY SHOP SIGN IN SCOTLAND.  THE MORTAR & PESTLE ARE TOOLS OF TRADDITIONAL PHARMACY, HENCE THEIR USE AS AN EASILY RECOGNIZEABLE VISUAL MOTIF.
  • 15. RECIPE  THE RECIPE SIGN APPEARS AT THE START OF PRESCRIPTIONS.  ALTHOUGH UNIVERSALLY ACCEPTED AS AN ABBREVIATION OF “RECIPE”.  LATIN FOR TAKE THOU  IT HAS ALSO BEEN SUGGESTEDD THAT IT IS THE ASTRONOMICAL SIGN OF THE PLANET JUPITER.
  • 16. PHARMACEUTICS  THE STUDY OF INTERFERANCE BETWEEN DRUG/MEDICINE AND BODY.  THE ART ND APPLIED SCIENCE OF DOSAGE FROM DESIGN.  DEALS WITH MANY ASPECTS OF INTERACTION BOTH INSIDE (INVIVO) AND OUT SIDE (IN VITRO) BODY.
  • 17. OBJECTIVE OF PHARMACEUTICS  TO DESIGN AND IMPLEMENT A DOSAGE FORM THAT IS BOTH SAFE AND EFFECTIVE FOR THE DRUG’S INTENDED USE!
  • 18. A BROAD FIELD THAT DRAWS FROM MANY DISCIPLINES  PHYSICAL CHEMISTRY (ORGANIC AND INORGANIC)  MEDICINAL CHEMISTRY  ANATOMY, PHYSIOLOGY  MICROBIOLOGY  ATOMIC PHYSICS  ENGINEERING (CHEMICAL, MATERIAL)
  • 19. PHARMACODYNAMICS SITE/MECHANISM OF ACTION, POTENCY, EFFICACY, ETC PHARMACOKINETICS absorption, distribution, metabolism, excretion
  • 20. PHARMACOKIENETICS  PHARMACOKINETICS DESCRIBED AS WHAT THE BODY DOES TO A DRUG, REFERS TO THE MOVEMENT OF DRUG INTO, THROUGH, AND OUT OF THE BODY;  ABSORPTION  DISTRIBUTION  ELIMINATION
  • 21. PHARMACOKIENETICS MODEL  ONE OF THE PRIMARY OBJECTIVES OF PHARMACOKINETIC MODELS IS TO DEVELOP A QUANTITATIVE METHOD TO DESCRIBE THE RELATIONSHIP OF DRUG CONCENTRATION, OR AMOUNT IN THE BODY, AS A FUNCTION OF TIME.
  • 22. USES OF PHARMACOKIENETIC NODEL  THERE ARE A WIDE VARIETY OF POTENTIAL USES FOR PHARMACOKINETIC MODELS, WHICH INCLUDE:  1. PREDICTION OF DRUG CONCENTRATION IN BLOOD/PLASMA OR TISSUE.  2. CALCULATION OF A DOSAGE REGIMEN.  3. QUANTITATIVE ASSESSMENT OF THE EFFECT OF DISEASE ON DRUG DISPOSITION.  4. ELUCIDATION OF THE MECHANISM OF DISEASE-INDUCED ALTERATIONS IN DRUG DISPOSITION.  5. DETERMINATION OF THE MECHANISM FOR DRUG–DRUG INTERACTIONS.  6. PREDICTION OF DRUG CONCENTRATION VERSUS EFFECT RELATIONSHIPS.
  • 23. TYPES OF PHARMACOKIENETICS MODELS  THERE ARE THREE PRIMARY TYPES OF PHARMACOKINETIC MODELS:  COMPARTMENTAL,  NON COMPARTMENTAL, AND  PHYSIOLOGICAL.
  • 24. PHARMACODYNAMICS  PHARMACODYNAMICS IS THE STUDY OF THE BIOCHEMICAL AND PHYSIOLOGICAL EFFECTS OF DRUGS ON THE BODY OR ON MICROORGANISMS OR PARASITES WITHIN OR ON THE BODY AND THE MECHANISMS OF DRUG ACTION AND THE RELATIONSHIP BETWEEN DRUG CONCENTRATION AND EFFECT
  • 25. DIFFERENCE IN PHARMACODYNAMICS & PHARMACOKIENETICS  PHARMACODYNAMICS IS OFTEN SUMMARIZED AS THE STUDY OF WHAT A DRUG DOES TO THE BODY, WHEREAS PHARMACOKINETICS IS THE STUDY OF WHAT THE BODY DOES TO A DRUG. PHARMACODYNAMICS IS SOMETIMES ABBREVIATED AS "PD", WHILE PHARMACOKINETICS CAN BE REFERRED TO AS "PK".
  • 26. DOSAGE FORM DESIGN STORAGE  RATE OF DEGRADATION (EXPIRY)  LIQUID/SOLID?  WHAT CONDITIONS?  TEMPERATURE  HUMIDITY  WHAT CONTAINER  HOW INERT IS IT? WHAT IS THE RISK FOR CONTAMINATION? COMPATIBILITY  ACTIVE VS. ACTIVE VS. “INERT” INGREDIENTS  CONTAINER (AGAIN)
  • 27. DOSAGE FORM DESIGN ORGANOLEPTIC CONSIDERATIONS  PHYSICAL APPEARANCE, TASTE, SMELL, TACTILITY, SIZE  “PHARMACEUTICAL ELEGANCE” MANUFACTURING  FOR A POWDER, HOW WELL DOES IT FLOW?
  • 28. WHAT YOU MUST KNOW TO DESIGN A DOSAGE FORM  PHYSICOCHEMICAL PROPERTIES OF THE DRUG  REACTIVITY, STABILITY  SOLUBILITY, ACID/BASE, SOLID STATE BEHAVIOR  BIOPHARMACEUTICAL CONSIDERATIONS  WHAT IS THE INTENDED SITE OF ACTION?  SYSTEMIC? TOPICAL?  WHERE/HOW WELL IS THE DRUG ABSORBED?  WHAT IS THE INTENDED ONSET OF ACTION?  IMMEDIATE-RELEASE, SUSTAINED- RELEASE, PULSE RELEASES
  • 29. DOSAGE FROMS  SOLID DOSAGE FORMS  POWDERS  TABLETS  CAPSULES (HARD, SOFT)  SUPPOSITORIES*  OINTMENT, CREAM, GEL, ETC.*  AEROSOL  LOZENGE  CIGARETTE  LIQUID DOSAGE FORMS  SOLUTIONS  SUSPENSIONS  (GAS)
  • 30. DOSAGE FORM POWDER  WHEN THE TERM ‘‘POWDER’’ IS REFERRED TO AS A DOSAGE FORM, IT REPRESENTS A FORMULATION THAT IS A MIXTURE OF POWDERED DRUG AND EXCIPIENTS. TABLETS  ACCORDING TO THE USP, TABLETS ARE SOLID DOSAGE FORMS, CONTAINING MEDICINAL SUBSTANCES WITH OR WITHOUT SUITABLE DILUENTS. THEY MAY BE CLASSED, ACCORDING TO THE METHOD OF MANUFACTURE, AS COMPRESSED TABLETS OR MOLDED TABLETS.
  • 31. DOSAGE FORM CAPSULES  CAPSULES ARE SOLID DOSAGE FORMS IN WHICH THE DRUG SUBSTANCE IS ENCLOSED IN EITHER A HARD OR SOFT, SOLUBLE CONTAINER OR SHELL OF A SUITABLE FORM OF GELATIN. SUPPOSITORIES  A SUPPOSITORY IS A DRUG DELIVERY SYSTEM THAT IS INSERTED INTO THE RECTUM (RECTAL SUPPOSITORY), VAGINA (VAGINAL SUPPOSITORY) OR URETHRA (URETHRAL SUPPOSITORY), WHERE IT DISSOLVES OR MELTS AND IS ABSORBED INTO THE BLOOD STREAM. THEY ARE USED TO DELIVER BOTH SYSTEMICALLY AND LOCALLY ACTING MEDICATIONS.
  • 32. DOSAGE FORM TOPICAL (OINTMENT, CREAM, GEL, ETC.)  MEDICATIONS ARE APPLIED TO THE SKIN OR ITS APPENDAGES OR INSERTED INTO BODY ORIfiCES IN LIQUID, SEMISOLID, OR SOLID FORM. AEROSOLE  THE TERM AEROSOL IS USED TO DENOTE VARIOUS SYSTEMS RANGING FROM THOSE OF A COLLOIDAL NATURE TO SYSTEMS CONSISTING OF PRESSURIZED PACKAGES. AEROSOLS HAVE BEEN DEfiNED AS COLLOIDAL SYSTEMS CONSISTING OF VERY fiNELY SUBDIVIDED LIQUID OR SOLID PARTICLES, DISPERSED IN AND SURROUNDED BY A GAS.
  • 33. DOSAGE FORM  LIQUID DOSAGE FORM (SOLUTION, SUSPENSION, EMULSION)  THESE DOSAGE FORMS ARE PREPARED BY EMPLOYING PHARMACEUTICALLY AND THERAPEUTICALLY ACCEPTABLE VEHICLES. THE ACTIVE INGREDIENT(S) MAY BE DISSOLVED IN AQUEOUS MEDIA, AN ORGANIC SOLVENT, OR A COMBINATION OF THE TWO, BY SUSPENDING THE DRUG (IF IT IS INSOLUBLE) IN AN APPROPRIATE MEDIUM OR BY INCORPORATING THE ACTIVE PHARMACEUTICAL INGREDIENT INTO ONE OF THE PHASES OF AN OIL AND WATER EMULSION.
  • 34. DOSAGE FROM  LIGHT  UV   RAYS
  • 35. ROUTES OF ADMINISTRATION  ORAL  PARENTERAL  IV, IM, SC, ETC.  OPHTHALMIC, OTIC  NASAL  RECTAL, VAGINAL, URETHRAL  BUCCAL  TOPICAL
  • 36. ANALYSIS OF PHARMACEUTICL PRODUCTS  THE PHARMACEUTICAL MANUFACTURER IS RESPONSIBLE FOR ENSURING THE QUALITY, PURITY, IDENTITY, AND STRENGTH OF EACH LOT OF DRUG PRODUCT MANUFACTURED. ONE MANDATORY CONTROL STRATEGY IS TO ENSURE THAT THE LOT ‘‘CONFORMS TO SPECIfiCATION,’’ WHICH MEANS THAT THE DRUG PRODUCT (FORMULATED PREPARATION), WHEN TESTED TO THE LISTED ANALYTICAL PROCEDURES, WILL MEET THE LISTED ACCEPTANCE CRITERIA.1 SPECIfiCATIONS ARE CRITICAL QUALITY STANDARDS.
  • 37. QUALITY ASSURANCE & QUALITY CONTROL IN PHARMA INDUSTRY  INDUSTRY,TO ENSURE COMPLIANCE WITH THESE GOVERNMENT REGULATIONS AND WITH THEIR OWN INTERNAL POLICIES AND PROCEDURES, HAS DEVELOPED VERY SOPHISTICATED QUALITY ORGANIZATIONS WITH WELL-DEFINED RESPONSIBILITIES.  IT HAS BEEN ACCEPTED THAT QA AND QC HAVE DIFFERENT FUNCTIONS WITHIN AN ORGANIZATION; ALTHOUGH BOTH ARE CONSIDERED PART OF THE QUALITY UNIT AS IDENTIFIED IN THE CODE OF FEDERAL REGULATIONS TITLE 21 (CFR)
  • 38. QUALITY ASSURANCE & QUALITY CONTROL IN PHARMA INDUSTRY  QC MOST COMMONLY FUNCTIONS TO TEST AND MEASURE MATERIAL AND PRODUCT.  QA ESTABLISHES SYSTEMS FOR ENSURING THE QUALITY OF THE PRODUCT. FIRMS MUST DECIDE UPON THE EXACT ROLES THEY WISH QC AND QA TO PERFORM IN OPERATIONS AND PUT THESE DEFINITIONS IN WRITING.
  • 39. OBJECTIVE OF THIS COURSE KNOWLEDGE SHARING OVERVIEW OF BASICS OF PHARMACY
  • 41. REFERENCE  REMINGTON – AN INTRODUCTION TO PHARMACY  http://www.msdmanuals.com/professional/clinical- pharmacology/pharmacokinetics/overview-of-pharmacokinetics  21 CFR