DDS tips q1

Why are DDSs important? (M1O5)

1. for accuracy and convenience in dosing of APIs

2. for protection of APIs inside and outside of body

3. to optimize API delivery to site of action

How are different APIs sourced? (M1O3)

• natural sources

  • plant sources

  • animal/microbial

  • mineral

• non-natural sources

  • synthetic - produced by chemical synthesis

  • semisynthetic - uses other compounds as starting materials to create novel compounds

• novel sources

  • biosynthetic - using biotechnology to engineer drugs

Where did the concept of the pharmacopeia come from? (M1O4)

• need for uniform standards as scientific bases for drugs developed

• “drug” + “to make”

• concept first expressed in Florence “nuovo receptario”

• Lyman Spalding submitted a plan in NY for a national pharmacopeia to be created

What are traditional dosage forms and what are devices? (M1O2)

• traditional: powders/granules, tablets, capsules, solutions, suspensions, emulsions

• devices: insulin pens, IV pumps, insulin pumps, metered dose inhalers, transdermal patches

How would you define powders/granules, tablets, and capsules? (M1O8)

• powder/granules - thorough mixtures of dry, finely to coarsely divided drugs plus excipients

• tablet - solid dosage formulations made of various shapes and colors

• capsule - solid dosage formulations in which the drug substance is enclosed within a shell usually formed from gelatin

What is the utility of granules vs powders? (M1O7)

• granules are larger and more circular

• granules flow better

• granules are more stable to atmospheric humidity

• granules are wetted better

What is the role of specific inactive ingredients (excipients) in powders/granules and tablets? (M1O10)

• diluents (bulking agents) - lactose, magnesium carbonate

• lubricants - magnesium stearate

• surfactants - sodium lauryl sulfate

• misc - ethanol, mineral oil, water

What are compounding techniques used in the compounding of powders/granules and capsules? (M1O11)

• trituration - grinding mixtures to make them homogeneous and of smaller particle size (use mortar and pestle)

• sieving - sizing particles through forcing through meshwork of uniform sizes

• geometric dilution - a technique for mixing two powders of unequal quanitity so uniformity of doses is achieved

What is the utility and desirable features associated with tablets? (M1O6)

• Utility:

  • natural (swallowing and absorption from GI tract)

  • versatile

  • mass produced, fast

• Desirable features

  • great integrity (free of cracks)

  • not too friable (easily crumbled)

  • maintain integrity during transport and storage, then come apart when ingested

Why is dissolution testing important? (M1O12)

• guide formulation development for new drugs

• serve as quality assurance measure in batch-to-batch production

• prove bioequivalence between brand and generic drugs

What advice would you give to patients taking an oral tablet? (M1O13)

• take with water

• check if need to be taken whole (do not chew crush or swallow)

• usually dont require refrigeration

What differentiates compounding from manufacturing? (M1O14)

• manufacturing

  • industrial scale

  • outside of relationship with patient

  • regulated by FDA

  • adheres to cGMPs

• compounding

  • based on a prescription

  • within a TRIAD relationship

  • regulated by BOP

  • adheres to cGCPs

What is the purpose of current Good Manufacturing Practices (cGMPs)? (M1O15)

• assure proper design, monitoring, and control of manufacturing processes

• assures identity, strength, quality, and purity of drug products

How often should you clean various areas of the segregated compounding area and monitoring the temperature in the storage area per USP <795>? (M1O16)

• work surfaces - beginning/end of shift, when contaminated, between compounding with different components

• floors - daily, when contaminated

• walls - every 3 months, when contaminated

• ceilings - visibly soiled, when contaminated

• storage shelving - every 3 months, when contaminated

What BUD do you assign a CNSP if you do not have data from the literature? (M1O18)

• non-preserved aqueous - 14 days

• preserved aqueous - 35 days

• nonaqueous - 90 days

• solid - 180 days