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PHARMACEUTICAL PRODUCTS

PHARMACEUTICAL PRODUCTS. WAYS IN WHICH DRUGS ARE TAKEN:. 1. INHALATION 2. INJECTION 3.SUPPOSITORIES 4. ORALLY. SIDE EFFECT:. A secondary effect Unwanted non therapeutic one Due to taking the specific drug. EFFECTS ON THE FUNCTIONING BODY. alteration of incoming sensory sensations

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PHARMACEUTICAL PRODUCTS

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  1. PHARMACEUTICAL PRODUCTS

  2. WAYS IN WHICH DRUGS ARE TAKEN: 1. INHALATION 2. INJECTION 3.SUPPOSITORIES 4. ORALLY

  3. SIDE EFFECT: A secondary effect Unwanted non therapeutic one Due to taking the specific drug

  4. EFFECTS ON THE FUNCTIONING BODY alteration of incoming sensory sensations alteration of mood or emotions alteration of physiological state (eg. consciousness, activity levels, physical coordination) Placebo effect

  5. MENTALSide Effects COMMON:AggressionAgitationAnxietyConfusionDepressionHallucinationsHostileHyperactiveImpulsiveIrritablePanickyPersonality disorderOverly excitedSeverely restless (akathisia)Sleeplessness (insomnia)SuicideWeakness (asthenia) MUSCULARSide Effects COMMON:Back painLeg crampsMuscle painShakiness (tremor)SpasmTirednessSwelling of legs and feetUnexplained muscle painWeakness

  6. ALLERGYSide Effects COMMON:Serious allergic reactionsSwelling of the face, lips, tongue, and/or throatDifficulty breathingDifficulty swallowing BLOODSide Effects COMMON:AnemiaDecreased levels of potassiumDecreased levels of sodiumDizzinessExcessive bleeding (sometimes fatal)Facial flushingFainting (syncope)Fast heartbeat (tachycardia)Heart attackHigh blood pressure (hypertension)Increased levels of potassiumLow blood pressure (hypotension)Low blood cell countsPalpitationsPerpetual erection (priapism)Postural hypotensionSlow heartbeat (bradycardia)Thrombosis (clotting) BONESide Effects COMMON:Bone lossBone pain Upper respiratory infection

  7. PAINSide Effects COMMON:Abdominal painBone painBreast painChest pain (angina)HeadacheHeartburnJoint painLeg crampsPainful menstruationVaginitis SENSESSide Effects COMMON:BlindnessBlurred visionColored visionRinging in the ears (tinnitus)Tingling sensation (paresthesia) SKINSide Effects COMMON:Allergic reactionItchingSkin rashSevere skin reactionsSweating

  8. BRAINSide Effects COMMON:AmnesiaDizziness (vertigo)SeizuresSpeech disorderStrokeTransient ischemic atychosisWorsening of epilepsy GASTRO-INTESTINALSide Effects COMMON:Abdominal painColitisConstipationDiarrheaDry mouthDyspepsiaIntestinal bleedingNauseaRectal bleedingStomach bleedingStomach painUpset Stomach (indigestion)Vomiting

  9. LIVER/ KIDNEYSide Effects COMMON:Acute kidney failureChronic kidney failureHepatitusJaundiceLiver damage LUNGS (Pulmonary Side Effects) COMMON:Cold symptomsCoughFlu-like symptomsLower respiratory infectionFluid in the lungs (pulmonary edema)Pulmonary thrombosisShortness of breath (dyspnea)Sore throat

  10. 3 DIFFERENT WAYS OF INJECTION: 1. INJECTABLES INTRAVENOUS (IV) injecting a liquid containing the drug directly into veins It is the quickest and most direct way of delivering a drug, and avoids the ‘first-pass effect’ The bolus of drug goes first to the heart and then to the general circulation.

  11. 2. INTRATHECAL Injected into the spinal cord This directly delivers the drug to the central nervous system

  12. 3. INTRAMUSCULAR Drug is injected into the muscle A lot of rich blood present causing the drug to go directly to the blood flow in the body Also the nerves in the muscle cause distribution in the nervous system

  13. 4. SUBCUTANEOUS(SC) Delivers drug below the fatty layer of skin Not painful because not a lot of blood or nerves Distributes to the body slowly Cannot distribute large amounts of drugs

  14. DRUG TOLERANCE Occurs in chronic users Takes a larger dose to achieve the same result Increases the possibility of overdose Increases the side effects Drugs suppress the central nervous system and effect heart rate and breathing

  15. THERAPEUTIC WINDOW

  16. DRUG PROCESS isolating the new product from existing species (plants, animals) or synthesized chemically/artificially subjecting the product to laboratory and clinical pharmacological studies (plant and animal testing) to demonstrate its effectiveness testing its effective dosage (ED5O) and lethal dosage (LD50) rates establishing its therapeutic index / window testing on humans in an initial clinical trial, on volunteers and patience, half of which are given a placebo processing the product through other tests elaborating on clinical situations having it approved by the drug administration, as either an OTC (over the counter) drug or prescription drug

  17. RESEARCH PROCESS Safe Efficacious has passed all regulatory requirements Discovery phase Clinical Testing

  18. DEVELOPMENT When the candidate molecule shows promise as a therapeutic, it must be characterized—the molecule’s size, shape, strengths and weaknesses, preferred conditions for maintaining function, toxicity, bioactivity, and bioavailability must be determined. Early stage pharmacology studies help to characterize the underlying mechanism of action of the compound.

  19. Formulation, Delivery, Packaging Development Drug developers must devise a formulation that ensures the proper drug delivery parameters. It is critical to begin looking ahead to clinical trials at this phase of the drug development process, this can be refined many times Scientists determine the drug’s stability—in the formulation itself, and for all the parameters involved with storage and shipment, such as heat, light, and time. The formulation must remain potent and sterile; and it must also remain safe (nontoxic).

  20. Preclinical Toxicology Testing And IND Application Preclinical testing analyzes the bioactivity, safety, and efficacy of the formulated drug product. During the preclinical stage of the development process, plans for clinical trials and an Investigative New Drug (IND) application are prepared. Studies taking place during the preclinical stage should be designed to support the clinical studies that will follow.

  21. TESTING Bioanalytical Testing Helps support clinical testing Characterization of the molecule Helps provide quality assurance and control

  22. CLINICAL TRIALS PHASE1 PHASE2 PHASE3 Testing on humans after testing on animals, with each phase the number of people increases to be tested

  23. STAY DRUG FREE!

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