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  1. physical form of a dose of medication
    dosage form or drug delievery system
  2. pharmaceutics
    general area of study concerned with the formulation, manufacuring, stability and effectiveness of pharmaceutical dosage form
  3. batch
    a specific quantitiy of a drug of uniform specified quality produced according to a single manufacturing order during the same cycle of manufacture
  4. quality control
    regulatory process through which industry measure actual quality perfomance compare it with standards and acts on the difference
  5. quality assurance
    activity of providing the evidence needed to establish confidence that the activities related to quality are being perfomed adequately
  6. gaseous dosage forms
    • medicinal gases, inhalation volatile anaesthetic
    • aerodispersions of solid particles( anti asthmatic inhalations) or liquid particles ( anti asthmatic inhalations or sprays)
  7. liquid dosage forms
    • solutions
    • emulsions
    • suspensions
  8. semisolid dosage forms
    • unshaped:
    • gels, creams, ointment and pastes
    • shaped
    • suppository and pessary
  9. classification: for systemic administration
    • P.O
    • S.L.
    • rectal
    • parenteral
    • transdermal
    • pulmonary
    • nasal
  10. classification: for local administration
    • occular, nasal, octic
    • buccal
    • rectal, vaginal
    • pulmonary
    • percutaneous, topical
  11. physiological ph value
    • oral cavity :7
    • esophagus 5-6
    • stomach 1.4 -3.5
    • duodenum 4-5
    • ileum 5 -8
  12. oral route ( Advantages)
    • convenient
    • absorption takes place along the whole length of the Gi
    • cheap
    • easily protable
  13. orla route (Disadvantage)
    • effect too slow for emergencis
    • unpleasent tast
    • irritation to gastric mucosa nausea and vomiting
    • destruction of durgs by gastric acid and digestive juices
    • hepatic firs pass
    • unable to use in unconscius patient
    • high risk of durg drug and drug nutrient interactions
  14. sublingual route (Advantages)
    tablets and spary
    • rapid absorption and onset of action
    • can be used in unconscious patients
    • avoid first pass effect
  15. Sublingual route (Disadvantage)
    • not effective if patient has a dry mouth
    • not effective if swallowed
    • unpleasant taste of some drugs
  16. retal route
    • solution, ointments and suppositories
    • superior hemorrhoidal vein( inferior mesentric > hepatic portal> liver)
    • middle and inferior( iliac vein> inferior vena cava)
  17. rectal route (advantages)
    • the effect of digestive enzymes is avoided
    • useful for unconscious patients and in vomiting
    • good option in pediatric population
    • may avoid first pass metabolism
  18. rectal route (Disadvantage)
    • absorption is slow an irregular and unreliable
    • patient acceptance
  19. depot preparation
    injection suspensions are slower acting than injectable solutions injections leading to slower absorption characteristis.
  20. parenteral route
    • sc...
    • im
    • iv
    • intradermal .... diagnostic measures arm and back
  21. prenteral route (Advantage)
    • for drugs that are poorly absorbed from the gastrointestinal tract
    • for agents such as insulin that are unstable in the GI
    • for unconscious patients
    • for emergencies
    • avoid hepatic first pass
  22. prenteral route (Disadvantage)
    • can't be removed in case of toxicity
    • sometimes more expensive
    • fromulation needs sterility
    • requiers trained person for administration
    • may be invasive
    • risk of pain/ irritation at the site of injection
  23. topical route (Advantages)
    • provides a controlled release
    • good compliance
    • delivery of the drug can be immediately discontinued
    • no degradation in the gI
    • avoid first pass
  24. topical route ( Disadvantage)
    • skin is a very effective barrier
    • high doses can not be accommodated and deliverd
    • local reactions
  25. pulmonary route (advantages)
    • fast druge delivery to blood
    • avoids first pass
    • no GI degradation
  26. Pulmonary route ( disadvantages)
    • coordination between activating the inhaler and inspiration may be required
    • might be difficult
  27. precutaneous route (Advantages)
    • applied where action desired
    • easy to use
  28. precutaneous route ( disadvantages)
    • inaccuracy of dose
    • stain clothes
    • allergic reaction
  29. function of inactive ingredients
    • to optamize manufacture and durge use
    • to guarantee the optimal release profile and the required stability
    • to keep manufacturing cost as low as possible
  30. water purification
    • reverse osmosis
    • distilation
    • ion exchange system
  31. vehicle
    • a carrying agent for a drug substance. they are used in formulating a variety of liquid dosage forms for oral and parenteral administration
    • ex: syrup
  32. adsorbant
    • an agent capable of holding other molecules onto its surface
    • ex: activated charchoal
  33. aerosol- propellant
    • an agent responsible for developing pressure within an aerosol container and expelling the product when the valve is opend
    • ex: hydrofluoroalkane
  34. encapsulating agent
    • an agent used to form thing shells for the purpose of enclosing a drug substance or drug fromulation
    • ex" gelatin
  35. colorant
    • used to impart color to liquid and solid pharmaceutical preparation
    • ex: FD&C RED NO 3 AND 2O
  36. Flavorant
    • used to impart a pleasant flavor and often odor to preparation
    • ex: peppermint oil
  37. sweetening agent
    • used to impart sweetness to prepartion
    • ex: aspartame and glycerin
  38. humaectant
    • used to prevent drying out of prepartion
    • ex: glycerin
  39. levigatin agent
    • a liquid used as an intervening agent to reduce particle size of a drug powder by grinding
    • ex: glycerin
  40. plasticizer
    • used as a component of film coating solution to enhance the spread of the coat over tablets and granules
    • ex: glycerin
  41. ointment base
    • the semisolid vehicle into which drug substance may be incoporated in preparing medicated ointments
    • ex: lanolin
  42. suppository base
    • used as a vehicle into which drug substance are incorporated
    • ex: cocoa butter
  43. surfactant
    • substances which absorb to surfaces or interfaces to reduce surface or interfacial tension
    • may be used as wetting agents detergents or emulsifying agent
    • ex: sodium lauryl sulfate and sorbitan monopalmitate
  44. emulsifying agent
    • used to promot and maintain the dispersion of finely subdivided particles of a liquid in a vehicle in which it is immiscible
    • ex: sorbital monopalmitate
  45. suspending agent
    • a viscosity increasing used to reduce the rate of sedmentation of drug particles dispersed throughout a vehicle in which they are not soluble
    • ex: hydroxylethyl cellulose and hydroxypropyl cellulose
  46. tablet binders
    • substances used to cause adhesion of powder particles in tablet granulations
    • ex: carboxymethylcellulose and gelatin
  47. tablet lubricant
    • substance used in tablet formulations to reduce friction during tablet compression
    • ex: stearic acid and zinc stearate
  48. diluent/fillers
    • inert substance used as fillers to create the desired bulk flow properties and compression characteristics in the preparation of tablets and capsules
    • ex: lactose
  49. tablet coating agent
    • used to coat a formed tablet for purpose of
    • protecting against durg decomposition by atmospheric oxygen or humidity
    • to provide a desired release pattern for the drug substance afteradministration
    • to maskthe tastorodorofthe drugsubstance
    • foraesthetic purposes
    • ex: hydroxyethyl cellulose and hydroxyprpyl methylcellulose
  50. tablet polishing agent
    • used to impart and attractive shine to coated tablets
    • ex: white wax and carnauba wax
  51. toniscity agent
    • used to render a solution similar in osmotic characteristics to physiologic fluids
    • ex: dextrose and soduim chloride
  52. antioxidants
    • decrease oxidation and increase stability
    • ex: vitamies a and E
  53. viscosity increasing agent
    • used to change consistency of a preparation to render it more resistant to flow
    • ex: methylcellulose
  54. preservatives
    • used to prevent microbila growth
    • ex: methy paraben and propyl paraben
  55. acidifying agent
    • used in liquid prepartions to provide acidic medium for product stability
    • ex: acetic acid and hydrochloric acid
  56. alkalinizing agent
    • used in liquid preparation to provide alkaline medium of product stability
    • ex: sodum hydroxide
  57. drug development
    is a term used to define the entire process of bringing a new drug or device to the market includes drug discovery/product development, pre clinical and clinical trails
  58. pre clinical drug development
    • space the gap
    • provid data on safety and efficacy
    • includes:
    • in vivo and vitro studies
    • drug manufacturing, formulation and packaging
  59. in vitro studies
    • assess drug effects on cells :
    • cytotoxcicity
    • assay of enzyme activity
    • receptor binding
    • protein interaction with signal transduction
  60. in vivo studies
    • Pk study- adme study
    • pd study
    • therapeutic index
    • toxicological study
  61. special study
    • effect on reproductive system and teratogenicity
    • mutagenicity
    • carcinogenicity
  62. IND
    • investigational new drug
    • fda for getting approval for testing drug in humans
  63. NID shows
    • the chemical structure of the compound
    • how it is thought to work in the body
    • any toxic effects found in the animals study
    • how the compund is manufactured
    • how, where and by whom the new studies will be conducted
  64. helsinki -1964
    • the clinical trail muct minimize the risk for participants
    • provision for care of the patients
    • terminate the trial when the risk becomes incompatible with the goals of the trial
    • adverse events to be reported immedialely to an ethical committe
  65. ethics committees
    • reviews a protocol befor the study is allowed to start
    • their job is to ensure that the risks of being in the study are not greater than the potential benefit
  66. IRB
    • institutional review board
    • to ensure the rights and welfare of the participants
    • review clinical tral protocols for ethical and legal issues
    • has the authority to approve, modify or disapprove it
    • they are monitored by the FDA
  67. informed consent
    • purpose
    • medicine to be studie
    • procedure and schedule
    • risks
    • potential benefits
    • alternatives to participation
    • confidentiality
  68. phase 1
    • healthy volunteers
    • purpose to determine safety profile
    • 1 identify metabolic and pharmacological effects of druge in humans
    • determine the side effects associated with increasing doses
    • gain early evidence on effectiveness
    • sufficient information about the drug's pharmacokinetics and pharmcological effects is required
    • 1-1.5 years
  69. phase 2
    • to obtain some preliminary data on the effectiveness of the drug for a particular indication in patients with the disease or condition
    • help determin the short term sid effects and risks
    • 2 years
  70. phase 3
    • expanded trails
    • additional information about effectiveness and safety
    • provid an adequate basis for extrapolating the results to the general population and transmitting that information in the physician labeling
    • 3-3.5 years
  71. NDA
    • new drug application
    • for FDa approve a new pharmaceutical for sale and marketing
    • several thousand pages
    • 1.5-2.5 years to read it
  72. NDA provide information
    • whether the drug is safe and effective in its proposed use and whether the benifites of the drug outweigh the risks
    • wether the drugs proposed labeling package insert is appropriate and what it should contain
    • whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve drug's identitiy strength quality and purity
  73. phase 4 (post marketing surveillance)
    • carried out once the drug is apporved and marketed
    • aim to find out safety profile in larg patient pool
    • might reveal new therapeutic indication
  74. ANDA
    • filed for generic products
    • following the expiration of patent term protection of the innovator drug/drug product
    • bioavilablity and bioequivalency studies
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