Pharmaceutics Exam 3 (Lecture 30- Nonsterile compounding/equipment)

Nonsterile Compounding

create/alter drug nonsterily

USP 795

Standards for compounding non-sterile preparations (CNSP) for humans and animals

Goals of USP 795

• minimize harm from:

  • microbial contamination

  • Variability in strength

  • Physical/Chemical incompatibilities

  • Bad quality ingredients

What dosage forms are required to comply with USP 795?

• Solid Oral

• Liquid Oral

• Rectal

• Vaginal

• Topical

• Nasal/sinus preparations

• Otic

What practices are NOT required to meet the requirements of USP 795?

• Single administered dose within 4 hours

• Nonsterile Radiopharmaceuticals

• Reconsititution

• Repackaging

• Splitting Tablets

What must people in non sterile compounding pharmacies do Under USP 795?

Demonstrate Knowledge/Compentancy every year

Undergo proper training

Master Formulation Records (MFR)

• Describes how CNSP is to be prepared

• Keeps record of procedures

• Name, Strength, dosage form

• measurements of all compenents

• Container/labeling requirements

• Complete preparing instructions

• By use date

• Any calculations

• Any quality control procedures

Compounding Records

• Kept for each script

• Name, strength, dosage form

• Date/time of preparation

• RX #

• Name, manufacturer, lot #, expiration date of each component

• Weight/measurement of each component

• Total qty.

• By use date

• Storage Requirements

• Calculations

• Description

• Quality Control Procedures

• MFR reference

What must you keep in mind when establishing Beyond Use dates (BUD)?

More water in product = more microbial growth

What is the BUD of Non-preserved Aqueous?

14 days (In fridge)

What is the BUD of Preserved Aqueous?

35 days (Fridge or Room Temp)

What is the BUD of Nonaqueous Oral Liquids?

90 days (Fridge or Room Temp)

What is the BUD of Other non aqueous?

180 days (Fridge or Room Temp)

Steps of Compounding

1. Preparation (Perform Calc, obtain proper equipment, wear PPE, clean area, get ingredients, read script)

2. Compounding

3. Final Check (Record/Label)

4. Sign off (date + initials)

5. Clean Up

Trueness

How close to expected value, reflects reality

Precision

How consistent or reproducible, repeatability

Accuracy

Combination of Trueness + Precision

Graduated Cylinders & Conical Graduates

• Measure liquids

• Cylinders more accurate

• Best to use when you’re not measuring less than 20-25% of total volume of graduate

Pipets

Measure small quantities greater than 1 mL

Micropipets

Measure volume less than 1 mL

(Aliquot method is usually used over this)

Droppers

Individually calibrated for the liquid dispensed (usually 20 gtts/mL)

Graduated Syringes

Calibrated for viscous liquids

Wedgewood Mortar & Pestles

• similar to porcelain, but unglazed

• strong grinding surface

• Best for powdering crystalline solids and other hard substances

Glass Mortars

• Best for liquid Preparation

• Mixing chemicals that stain or are oily

Porcelain Mortars

Ideal for blending powders and pulverizing soft aggregates or crystals