Pharmacology and Pharmaceutical Compounding: USP Standards, Drug Absorption, and Delivery Routes

Physiological factors influence nasal drug absorbtion

blood flow, mucocillary clearance, enzymatic degredation, transporters and effux systems

what is USP

United States Pharmacopeia. Sets standards for compounding but does not enforce it FDA enforces.

What does FDA do

enforces 503 b and manufacturers.

what is 795

Non-sterile compounding

Which USP chapter provides requirements for creating MFR's

795 and 797

Types of mortars and pestles and uses?

Wedge wood mortar and pestle: more porous and stains easily best for crystalline solids and other hard substances.

glass mortars should mix liquid preperations for mixing chemicals that stain or are oily

porcelain mortars have a smoother surface than wedge wood and are ideal for blending powders and pulverizing soft agregates or crystals.

What is proper USP nomenclature and harmonization?

Drug, Root, Vehicle

Know different diffusion pathways at olfactory bulb

nasal mucosa to olfactory bulb along neurons evengtuall to brain via trigeminal nerves

why would you use rectal over oral administration?

If the drug has poor stability, solubility, or permeabililty

Know about fusion molding

melt base, disperse drug in melted base, pour into mold, once congealed remove from mold. dont use cold mold, dont stop until all cabities have been filled, lube aluminum molds. some bases contract like cocoa butter or peg, some dont like MBK and glycerinated gelatin.

know methylcelllulose in oral solutions

neutral ph, clear appealing liquid, viscosifier, less susceptible to mold

know bases for suppositories.

cocoa butter, MBK. ill add more after the lecture monday

different types of topical preperations and their qualities

hydrocarbons: good emollient, protective, occlusive, nonwater washable and stays on skin. poor acceptance due to greasy nature. cant absorb water and only limited alcohol. ex. Vaseline

W/O protective, eclusive, emollient properties, do not wash off skin easy, absorb liquids. poor patient acceptance and hard to wash off. ex: eucerin

O/W non greasy and asthetically pleasing. Lotions absorb some water or alc and can be washed off. allow dissipation of fluids from injured skin. less protective, emollient, and occulsive than the others and requires a preservative. dry out becuase of water evap. absorb 30% without thinking ex. lotions

know wet vs dry gum

4 parts oil 2 parts water and 1 part emulsifier.

dry gum is 1 part gum levigated with 4 parts oil and then 2 parts of water is added

wet gum is 1 part gum levigated with 2 parts water and 4 parts of oil is added.

know emulsion types W/O vs O/W

Water is greater than 45% than it is oil in water and less than 45% is water in oil. HLB less than 8 is water in oil greater that 9 is oil in water.

know definitions of levigation and tritiration

levigation decreases particle size of powders via titurating them with a mortar and pestle or spatula with an ointment slab, mostly wet grinding

tritiration dry grinding

Know the the thermodynamic and kinetic of nano, micro, and macro emulsions

macro- 1-100 micrometers, spherical thermodynamically unstable, weak, and kinetically unstable

nano- 20-500 nanometers spherical, thermodynamically unstable, kinetically stable

microemulsions 10-200 nanometers, spherical, lamellar, thermodynamically stable.

know polaxamers

synthetic, non-toxic block copolymers (PEO-PPO-PEO) used widely in medicine as surfactants, solubilizers, and emulsifiers, famous for forming micelles and thermo-reversible hydrogels, enabling controlled drug delivery, especially for hydrophobic drugs, and used in toothpaste, eye drops, and cancer treatments due to their amphiphilic nature and biocompatibility. could not find in notes straight from google.

know surfactant classes

Anionic. Cationic , Nonionic , and Amphoteric/Zwitterionic. ( not sure if correct checked on google)

know advantages of syrups

Sweet visocous oral solution that contains one or more active ingredients. Disguise bad taste, soothing characteristics, little or no alc, easy to adjust doasage for children.

know rectal drugs are absorbed

Rectal Route minimizes first pass metabolism of drugs, three emroidal veins, superficial, middle, and inferiror. Superficial drains upper rectum to portal, while middle and inferior veins drain from lower rectum to venous circulation

know what is considered making oral solution

will it dissolve, time to disolve, stay in solution, stay stable, chemicla compatibility, is preservative needed?

know nose anatomy

I cant upload pictures just check back in notes

gravitation seperation

is a physical instability where components of a mixture settle due to differences in density and particle size. This is a critical concern, particularly in liquid formulations like suspensions and emulsions, as it can lead to inaccurate dosing and reduced efficacy if the components are not uniformly distributed when administered

intranasal delivery to brain

Intranasal drug is transported olfactory route to the CNS, Drug goes from olfacotry sensor neurons then projected to olfactory bulb,.

flocculation

particles form loose aggregates/ flocs induced by electrical charge shifts or adding polymers/surfactants. sediment forms quickley but it is loose and can be resuspended bu shaking. Can adhere to the container walls.

extracellular routes pass through

tight junctions, paracellular clefts, lamina propria, perineural space and ultimatley the subarachnoid space where it is transoirted to the distal targets around the CNS.

coalescence

droplets fuse by direct interaction into larger drops

ostwald ripening

small droplets are eaten by larger ones. transfer of internal phases

phase seperation

the process where a mixture demixes into two or more distinct phases, like oil and water, driven by thermodynamics

USP 795

non sterile preperations. must comply in 503 A and B

USP 797

Guidelines for sterile compounding. state of enviromental control under which they are compounded, probability for microbial growth during the time stored, time period they must be used in. Must comply in 503 A and B

who regulates 503 A

state board of pharmacy.

who regulates 503b

state and fda

who regulates manufacturers

only FDA