DOSAGE DDD

Diagnosis

To determine the presence or cause of a disease (e.g., Contrast agents, diagnostic reagents used in laboratory tests).

Mitigation

To alleviate, lessen, or ease the severity of signs and symptoms of a disease without curing it (e.g., Pain relievers, cough suppressants, antiemetics).

Treatment

To manage or control a disease condition and make someone healthy again (e.g., Antihypertensives, chronic disease medications)

Prevention

To stop disease before it occurs or reduce the risk of acquiring it (e.g., Vaccines, vitamins, prophylactic antibiotics).

Cure

To completely eliminate a disease or pathogen from the body (e.g., Curative antibiotic regimens, antiparasitics).

Dosage forms

are specialized preparations designed to contain a specified quantity of medication for ease, safety, and accuracy of dosage administration.

1. physical stability

2. chemical stability

3. microbiological stability

4. therapeutic stability

5. toxicologic stability

5 types of product stability

DRUG DEGRADATION

Stability changes that reduce the quality, safety or efficacy of a drug product

Hydrolysis

a solvolysis process in which drug molecules interact with water, breaking chemical bonds to yield breakdown products of different chemical constitution

esters, amides, lactones, and lactams

Functional groups highly prone to hydrolysis include…

oxidation

involves the loss of electrons or gain of oxygen by an atom or molecule

preservatives

added to dosage forms to prevent microbial growth during manufacture, storage, and patient use.

15-20%

Products NOT Requiring Preservatives: Alcoholic and hydroalcoholic solutions containing __ alcohol

elixirs, tinctures, spirits

Products NOT Requiring Preservatives:

benzyl alcohol, phenol, parabens

Commonly used preservatives in sterile products: ___ in low concentration

Age Group	Maximum allowable alcohol content
> 6 yrs	0.5% max
6-12 yrs	5.0% max
< 12 yrs & adult	10.0 % max

Age Group	Maximum allowable alcohol content
> 6 yrs
6-12 yrs
< 12 yrs & adult

FDA Maximum Alcohol Content Limits for OTC Oral Preparations

Cinnamon, Raspberry, Orange

Flavoring Agent: Mask salty tastes (chlorides of Na, K, NH4)

Cocoa

Flavoring Agent: Masks bitter tastes (alkaloids, Epsom salt)

Citrus & Fruit Flavors

Flavoring Agent: Combat sour or acidic tastes.

Organic Esters, Alcohols, Aldehydes

Flavoring Agent: Impart general pleasant fruity tastes

Sucrose

Commonly used sweetener; derived from sugar cane/beet

glycerin

less sweet than sucrose

Saccharin

300x sweeter than sucrose; bitter aftertaste; carcinogenic potential in animal studies.

Aspartame

180-200x sweeter than sucrose; contraindicated in Phenylketonuria (PKU).

Cyclamate

30x sweeter than sucrose; banned in several regions due to safety concerns

Acesulfame Potassium

200x sweeter than sucrose; artificial non-caloric sweetener

Sucralose

600x sweeter than sucrose

Stevia Powder

Natural, non-toxic sweetener; 30x sweeter than sucrose.

FD&C Yellow No. 5 (Tartrazine)

(color additives) Can trigger allergic reactions in patients sensitive to Aspirin. Must be explicitly labeled

FD&C Red No. 4

(color additives) Restricted to external use only due to unresolved safety questions

FD&C Red No. 2 (Amaranth)

(color additives) Approval withdrawn due to carcinogenicity in animal studies

container

Holds the article and is or may be in direct contact with it.

immediate container

In direct contact with the product at all times.

Closure

Closes the container to prevent loss, leakage, or contamination

Well-Closed Container

Protects contents from extraneous solids and loss of article under ordinary conditions of handling, shipment, storage and distribution.

Tightly-Closed Container

Protects the contents from contamination by extraneous solids, liquids, or vapors, from the loss of the drug and from efflorescence, deliquescence, or evaporation under the usual conditions of handling, shipment, storage and distribution

Deliquescent

A substance that absorbs moisture from the air until it dissolves in its own absorbed water.

Efflorescence

The process where a crystalline hydrate loses water of crystallization, forming a dry, powdery surface

Evaporation

The conversion of a liquid into vapor that escapes into the atmosphere

Hermetic Container

Impervious to air or any other gas under customary conditions; essential for sterile parenteral products

Light-Resistant Container

Reduces light transmission (UV) to protect light-sensitive drugs; commonly amber glass or opaque plastic

Single-dose container (unit dose package)

one that holds a quantity of drug intended as a single dose and when opened cannot be resealed with assurance that sterility has been maintained

Multiple-dose container

one that contains more than a single dose of medication and permits withdrawal of successive portions of the contents without changing the strength or endangering the quality of the remaining portions.

Type III Glass

Soda-lime glass (Used for non-aqueous parenterals or dry powders)

Type I Glass

Highly resistant borosilicate glass (Best chemical resistance; used for parenterals).

Type II Glass

Treated soda-lime glass (Used for acidic/neutral parenterals).

Type NP

General purpose soda-lime glass (Non-parenteral preparations only).

PVC (Polyvinyl Chloride)

rigid, good clarity for blister packs; not gamma sterilizable)

PET, APET, PETG

Plastic Gamma radiation sterilizable with high clarity

-20C to -10C

freezer temp

not exceeding 8C

cold place

2-8 C

Refrigerator

prevailing temp in working area

room temperature

20-25 C ; 15-30C

controlled room temp

30-40C

warm temp

above 40C

excessive heat temp

CLASSIFICATION	SIEVE NO.	%
Very Coarse	8	100% pass through No. 8; ≤20% pass through No. 60
Coarse	20	100% pass through No. 20; ≤40% pass through No. 60
Moderately Coarse	40	100% pass through No. 40; ≤40% pass through No. 80
Fine	60	100% pass through No. 60; ≤40% pass through No. 100
Very Fine	80	100% pass through No. 80; no limit to fineness

CLASSIFICATION	SIEVE NO.	%
	8
	20
	40
	60
	80

Trituration

Continuous grinding/rubbing of dry solid in a mortar and pestle (small scale) or mills/pulverizers (large scale).

Levigation

Trituration in the presence of a small amount of liquid (levigating agent) in which the solid is insoluble

Mineral oil for hydrophobic bases; Glycerin for hydrophilic bases

Levigation: __ for hydrophobic bases; __ for hydrophilic bases

Pulverization by Intervention

Size reduction using a volatile solvent (alcohol/acetone) to dissolve gummy/resinous substances (e.g., Camphor, Iodine), followed by solvent evaporation leaving fine crystals

Spatulation

Used to blend small amounts of powders on a sheet of paper or pill Tile

Trituration

Maybe employed both to comminute and to mix powder

Glass

mortar best used for Solution. Suspension, Moist or volatile substances

Porcelain

mortar used for Dry powders, Chemical substances, General mixing

Wedgewood

mortal used for Crystalline substances, Moderately tough materials

Tumbling

is the process of mixing powders in a large container rotated by a motorized process.

Tumbling

Widely used in large volume powder mixers that use motorized blades to blend the powders in a large mixing vessel

Geometric Dilution

MANDATORY method for blending potent drugs with large amounts of diluent

DENTRIFICES

is a substance used with a toothbrush for the purpose of cleaning the accessible surface of the teeth

INSUFFLATION

finely divided powders that are intended to be applied in a body cavity, such as the ears, nose, vgina, tooth socket, or throat. With the use of bulb applicator

Chartulae

latin name of divided powders

DIVIDED POWDERS

dispensed in the form of individual doses and generally dispensed in papers, properly folded

individual weighing and block and divide method

Methods of dividing powder

Simple Bond Paper

Opaque paper with no moisture resistance; used for non-hygroscopic powders

Waxed Paper

Transparent waterproof paper; ideal for hygroscopic or deliquescent drugs

Vegetable Parchment

Thin, semi-opaque, moisture-resistant paper

Glassine Paper

Glazed, transparent moisture-resistant paper. Can be used to packed volatile substances

1 to 6 𝜇m in diameter

powder size of aerosol powders

4 to 12-sieve size range

granules size: __ sieve size range

No. 12-20

Sieve size for tablet formulation:

citric acid

dry granulation method

__ serves as a binding agent

Effervescent Granulated Salts

Are granules or coarse to very coarse powders containing a soluble medicinal agent in a dry mixture

sodium bicarbonate(alkalinizer), citric acid (acidifier), and tartaric acid (acidifier)

Effervescent Granulated Salts is composed of

1 citric: 2 tartaric

ratio of citric and tartaric acid in Effervescent Granulated Salts

tartaric acid

if used alone as sole acid, the resulting granules readily lose their firmness and crumble.

citric acid

if used alone as sole acid, the resulting granules become sticky mixture difficult to granulate

CAPSULES

solid dosage forms in which the medicinal agents and/or inert substances are enclosed in a small gelatin shell

Hard Gelatin Capsules

Used by community pharmacist in extemporaneous compounding of prescriptions

0.15% sulfur dioxide

used to prevent decomposition of hard gelatin capsules

13-16%

moisture content of hard gelatin capsule

Soft Gelatin Capsules (SGC)

Soft, globular gelatin shell thicker than HGC

Soft Gelatin Capsules (SGC)

Hermetically seal and encapsulate liquids, suspensions, pasty materials or dry powders

Gelatin

Obtained by partial hydrolysis of collagen from skin, connective tissues, and bones of animals

Type A Gelatin

Derived from pork skin via acid processing.

Type B Gelatin

Derived from animal bones and skins via alkaline processing.

Vegetable Shells

Prepared from Hydroxypropyl Methylcellulose (HPMC) derived from plant cellulose

lactose, microcrystalline cellulose and starch

example of diluents or fillers HGC

pregelatinized starch, croscarmellose, sodium starch glycolate

examples of disintegrants HGC

Fumed silicon dioxide, magnesium stearate, calcium stearate, stearic acid or talc

examples of lubricants or glidants HGC