intro to pharmaceutics

• pharmaceutics


  refers to the wide range of subject areas that are all associated with the steps to which a drug is subjected towards the end of its development
• why do we need to turn a drug into a drug delivery system

  to make it effective and safely taken by the patient, rendered stable
• pharmaceutics


  focuses of the new chemical entity prepared as a medication: process of turning a new chemical entity into a medication that can be safely and effectively used by the patients in the community
• pharmaceutics is a multidisciplinary science because?

  1) formulation design and 2) pharmacokinetic design (ADME, what the body does to the drug) & study the stability of the API
• areas of pharmaceutics

  physical pharmacy, biopharmaceutics, dosage form design, compounding, manufacturing, product performance testing, microbiology
• product performance testing


  quality control testing on a small scale
• pharmaceutical microbiology


  evaluating microbial content
• dosage form design


  design and formulation of medicine (types of tablets, solutions, suspensions) needed for medication counseling
• difference compounding and manufacturing

  compounding: small-scale preps for dosage forms; manufacturing: for large-scale dosage form
• product performance testing


  evaluate the meds based on design specifications and intended use (ex. green that should have been red does not pass this test, specifically called design specification)
• to eliminate microorganisms in medicines (ex. the presence of preservatives)


  aim in compounding dosage forms
• physical pharmacy


  dealt with the quantitative and theoretical principles of physiochemical principles
• physical pharmacy

  basic physical chemistry necessary for effective design of dosage forms
• biopharmaceutics 


  examines the interrelationship of physical/chemical properties of the drug, dosage form in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption
• pharmacokinetics in biopharmaceutics

  studies liberation and absorption
• biopharmaceutics only covers up until drug absorption (a in ADME). t/f

  true
• compounding (acc to RA 10918)


  referred as drug preparation (mixing, packaging, calculating); sum of processes performed buy a pharmacist in drug preparation
• compounding (acc to USP)


  practitioner/patient /pharmacist-compounder relationship (content similar to previous)
• patient-specific medications


  requested by physicians, small-scale and becomes freshly prepared (extemporaneously compounded)
• manufacturing

  packaging of meds
• production


  large-scale compounding
• compounding, according to USP-NF includes:

  -preparation of drug dosage forms for both human and animal patients - preparation of drugs or devices in anticipation of prescription drug orders (ito ang gamit, ito ang gagawin), - reconstitution or manipulation of commercial products that may require the addition of one or more ingredients - prep of drugs/devices for the purposes of research and chemical analysis -prep of drugs when permitted by the federal /state law
• why do we perform compounding?

  1)not commercially available 2)allergic to excipients in commercially available products 3) children's medications be prep as liquids: to enhance flavor for compliance 4) unstable medications that require preparation 5) some are reported in literature but not manufactured 6) some physicians need to deliver drugs in innovative ways and request them 7) for veterinary patients and these drugs mut be compounded
• USP Chapter 795


  pharmaceutical compounding nonsterile preparations is based on?
• categories of compounding (USP 795: nonsterile preps)

  simple, moderate and complex
• simple compounding


  reconstitution or manipulation of commercial product as directed by the manufacturer, USP compounding monograph or peer-reviewed journal with all specifications
• example of simple compounding


  reconstitution and manipulation of drug
• moderate compounding


  tweak of formulations and then compounded (has adjustments and heavy calculation)
• you do not need stability data to perform moderate compounding. (t/f)?

  true
• complex compounding


  requires special training and environment, facilities and equipment and procedures to ensure appropriate therapeutic outcomes
• examples of complex compounding

  sterile compounding, radiopharmaceutical compounding
• compounder


  compound of acceptable strength, quality and purity in accordance with prescription or medication
• compounder must adhere to ?

  general principles of compounding
• compounding facilities must have the ff characteristics:

  adequate space for compounding & orderly placement of equipment
• compounding equipment


  appropriate design & capacity, surface that contact the product components, routinely inspected and calibrated, must appropriately cleaned after use, dedicated equipment for preps
• plastics must be regularly cleaned because:

  not wiping off leads to the leaving of biofilm at container, leading to brown deposits that are full of bacteria
• finished compounded components (FCC)


  components must have expiration date (API and excipient)
• expired drugs are not safe. t/f?

  false, safe but may have lower potency
• components with no expiration dates must have the following:

  date of receipt & assigning a conservative expiration date based on the nature of component (max 3 yrs, pero sa lab 2 yrs lang pweds)
• beyond-use date (BUD)

  date after which a compounded preparation shall not be used and is determined from the date when the preparation is compounded