Pharmaceutical Dosage Form Lab prep 6-18

8/11/2019 Pharmaceutical Dosage Form Lab prep 6-18

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PHARMACEUTICAL DOSAGE FORMS LAB

REVIEWER

#6 GLYCERIN SUPPOSITORIES

CATEGORY: suppository

SYNONYM:glycerina

LABEL: red label

CONTAINER: suppository bottle

Suppository - solid dosage form intended for insertion

into the body orifices where they melt, soften,

dissolvem and exert localizied or systemic effect.

5 TYPES OF SUPPOSITORIES

1. rectal - cylindrical or bullet shape

- 32 mm (1 inch)

- 2g adult; 1g children

Use: glyercinlaxative effect

Sodium stearate(Soap); solidifying agent

Cathartic acts directly on colonic mucosa

to produce normal peristalsis. Not

appreciably affects the motility of small

intestine

Relieve pruritus ani pain associated w/hemorrhoids

constipation

2. urethral (bougies or inserts) slender, pencil

shaped.

Male:4g; 140 mm long, 3-6 mm diameter

Female:2g; 60-70 mm long

Use: dilatation of uterus

Anti-infective agent

Erectile dysfunction

Tx of local infection

3. vaginal (pessaries) - globular, oviform, cone-shaped;

5 grams.

Caused by: Trichomonas vaginalis, Candida (Monilia)

albicans, Haemophilus vaginalis

Estrogenic substances (dienestrol) used to

restore the vaginal mucosa to its normal state.

Vaginal tablets (vaginal inserts) - easier to

manufacture, more stable, and less messy.

Anti-infective

w/ homonal substances

Tablet lubricantMagnesium stearate

Disintegrating agent- startch

Use: anti-fungal

Anti-infective

Contraceptive (w/ spermicide)

4. otic (aural)pencil-shaped

5. nasal (burginarium)

pencil-shaped

CRITERIA FOR SUPPOSITORIES

1. melts at body temperature

2. firm at room temperature

3. yields at clear melt

4. inert and compatible with other agent

5. wetting and emulsifying

6. acid value (


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- PEG liquid (300, 400, 600)

- PEG semi-solid

- PEG solid- wax ( > 1000)- clear colorless liquid

METHODS OF PREPARATION

1. hand rollingmixing and rolling in a pile tile.

2. compression - more elegant in appearnce

-very simple avoid sedimentation

-not for large manufacturing

-mix -> supp. Compression device -> apply pressure

-> cool

3. fusion method

-

melting of all ingredients

-

pour directly to mold-

freeze

-

wrap in Aluminum foil

#7 COLD CREAM

CATEGORY: cream

SYNONYM: petrolatum rose water ointment

USES: emollient, cleansing cream, ointment base

CONTAINER: 15 g ointment jar

Creamssemisolid preparations containing one or more

medicinal agents dissolves or dispersed in either o/w or

w/o emulsion or in another type of water-washable

base.

Easily spread and remove than ointment

Lighter, less viscous

Impart pseudo-plastic flow when applied

2 TYPES OF CREAMS

1. oil-in-watervanishing cream (galens cerate)

Example: shaving cream, hand cream, foundation

cream

2. water-in-oil- imparts oily feeling on skin

Example: cold cream (petrolatum rose water

ointment), emollient cream

Substitutes for Spermaceti Wax

a. cetyl ester wax

b. cethy alcohol

why is almond oil changed ito mineral oil?

More stable cold cream

But if almond oil is used, better emollientproperty

#8 WHITE OINTMENT

SYNONYM: salve, chrisma, unguentum album

unguentum simplex

USE: protective, emollient, lubricant


Ointment semisolid preparation intended fo

external application to skin and mucous membrane.

2 TYPES OF OINTMENT:

1. medicated- w/ active ingredient

2. non-medicated- ointment bases. Serves as vehicles

for application of medicinal substances

Medicaments are reduced to impalpable

powder before incorporation into a base to

reduce grittiness and form a very smooth

nucleus for a smooth homogeous ointment.


1. fusion

2. mechanical incorporation performed by trituration

in a mortar or on a slab with spatula is a process known

as levigation.

Unguator

4 TYPES OF OINTMENT BASES

1. oleaginous basesaka hydrocarbon bases

Have emollient effect after application

Water insoluble

Non-washable

Cannot absorb water

Oily, occlusive, lack cosmetic appeal


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Examples:

a. Petrolatum, USP good base for insoluble

ingredients

ex. vaseline

b. White petrolatum, USPyellow wax is decolorized

ex. Whitevaseline

c. Yellow Ointment, USPaka simple ointment;

- yellow wax- purified wax

obtained from honeycomb of the bee Apis mellifera

d. white ointment USP - white wax (bleached and

purified yellow wax)

e. Lanolin derivatives

e. Synthetic estersconstituents of oleaginous

- glyceryl monostearate, butyl

stearate, isopropyl lanolate , stearyl alcohol

2. Absorption Bases

Water insoluble

Non-washable

Can absorb water

Anhydrous

Oily, occlusive, lacks cosmetic appeal

Examples:

a. Hydrophilic petrolatumw/o emulsifier

b. Aquaphor has the capacity to absorb up to 3x its

weight in water

c. Aquabase

d. Wool fat (anhydrous lanolin) from wool of sheep

(Ovis aries)

Higher percentage of cholesterol Ability to absorb twice its weight

3. Water-Removable bases o/w emulsions; aka

emulsion bases.

2 types:

a. Water in oil

water insoluble

non-washable

can absorb water

contains water

Examples:

cold cream (petrolatum rose water ointment)

Lanolin (hydrous wool fat)

Hydrophilic ointment

Vanishing creams

b. Oil in water

water insoluble

water washable

can absorb water

contains water

Examples:

Hydrophilic ointment

Velvachol

Unibase

Acid mantle

Dermabase

Vanicream

Humectantshydrating agent

Glycerin

Propylene glycol

Sorbitol 70%

4. Water Soluble bases

Water soluble

Water washable

Can absorb water

Anhydrous or hydrous

All water soluble, no oil phase

Examples:polyethylene glycol ointment

Veegum

Methods of Preparation:

1.

Fusion heating all ingredients. Let cool and

congeal.

2.

Mechanical incorporation - performed by

trituration in a mortar or on a slab with spatula

is a process knwon as levigation.

COMPEDIAL REQUIREMENTS FOR OINTMENTS:

1.

Microbial content test for absence o

Staphyloccocus aureus and Pseudomonas

aeruginosa.


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Addition of preservatives such as

methyparaben, propylparaben,phenols, benzoic

acid, sorbic acid, and quarternary ammonium

salts

2.

Minimum fill to ensure proper contents

compared with labeled amount.

- 30% max (overage)

- 10% minimum

3.

Packaging, storing, and labeling

Packaging jar: glass, plastics ( DO NOT POUR

WHILE HOT)

-dispensing jars: plastic

-tubes: plasitc, tin, aluminum

Labelingprotect w/ tape

- Dual labels

Storagestore in a cool place

4.

Sterility test and metal particles content for

ophthalmic ointment

5.

non-gritty non sand-like feeling to be

achieved by heavy trituration.

SELECTION OF APPROPRIATE BASE:

Topical or percutaneous drug absorption

Release rate Occlusion

Stability of the drug

Effect of drug on ointment base

Easy removable

Characteristics of surface for application

#9 ZINC OXIDE OINTMENT

SYNONYM: Zinc oxide unguentum

USE: Tx and Prevention for diaper rash (protectant)


Active ingredient: ZnO

#10 SULFUR OINTMENT

SYNONYM: Unguentum sulfuris, Unguentum de Azufre

USE: Tx for scabies, ketolytic, acne vulgaris

Active ingredient: precipitated sulfur make a

smoother ointment than any other sulfur. Provides

greater reactive surfaces.

#11 CINNAMON WATER

SYNONYM: cassia oil, cassio nare

USE: flavored vehicle for internal aqueous solution

carminative

DESCRIPTION OF FINAL PRODUCT: clear, saturated

solution

CONTAINER: 30 ml narrow amber bottle

#12 CONCENTRATED PEPPERMINT WATER

SYNONYM: Aqua Mint

USE: flavoring vehicle, carminative


DESCRIPTION OF FINAL PRODUCT: clear, saturated

solution

Computed by alligation alternate (x method)

Aromatic water- clear, aqueous soution saturated with

volatile oils or other aromatic or volatile substances.

Should be free from empyreumatic (smole-like

and other foreign odor.


1. distillation - most satisfactory methos of preparation

but the slowest and most expensive of the 2 methods.

Example:Strong Rose Water

Cohobationprocess of repeatedly using the distillate

to distille with fresh portions of flowers/ plant materials

to minimize loss of water soluble components.

Example: Orange or Rose flowers

2. Solution

2a. Direct solution method - prepared by repeatedly

shaking and set aside or 12 hours, filtered through

wetted filter paper and qs ad.

Example: cinnamon water


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2b. Alternate solution method prepared by

incorporating the volatile oil with talc or siliceous earth

or pulped filter paper, agitate for 10 mins, filtered and

qs ad.

Example: concentrated peppermint water

Dispersing agent - surface of volatile substances

ensuring more rapid saturation of water and forms anefficient filter aid for a clearer solution.

#13 CALCIUM HYDROXIDE TOPICAL SOLUTION

CATEGORY: astringent

DESCRIPTION OF FINAL PRODUCT: clear, colorless

solution

SYNONYM: hydrated lime, lime water, liqoud calcis

Ca(OH)2+ CO2 CaCO3+ H2O

CONTAINER: 30 ml narrow mouth flint bottle

REMARKS:

Should be stored in well-filled, tightly stoppered

containers to determine the absorption of CO2and should be kept in the cool place to avoid

degradation.

Best accomplished by the use of a siphon with

care not to entrain the residue.

Prepared by simple solution

NOTE: CaOH is more solublein cold water

#14 STRONG IODINE SOLUTION

SYNONYM: Liquor Iodi Fortis, Lugols soln

USE: antiseptic


REMARKS:

Iodine crystals stains hand and jewelries

1:2950

Very volatile

Very reactive to metal use porcelain

or very hard rubber spatula

Addition of KI to increase solubility

Prepared by simple solution

#15 MAGNESIUM CITRATE ORAL SOLUTION

SYNONYM: Milk of Magnesia, Ascapate of Magnesia

USE: saline cathartic

DESCRIPTION OF FINAL PRODUCT: colorless to slightly

yellow clear effervescent liquid having a sweetaciduloud taste and a lemon flavor.

REMARKS:

NOTE: CaOH is more solublein cold water

Is has tendency to deposit a crystalline solid

upon standing

Official MgCo3 a basic hydrated MgCO3, or a

normal hydrated MgCO3

STORAGE: cool place preferably a ref keepping the corkor rubber liner moist and swollen maintaining airtight

seal between cap and bottle.

CONTAINER: 120 ml wide mouth flint bottle

Solutions liquid preparations that contain one o

more chemical substances dissolves in a suitable solven

or mixture of mutually miscible substances.

Homogenous mixture

Relative Terms of Solubility

Descriptive termParts of solvent required

for 1 part of solute

Very soluble 10,000

METHODS OF PREPARATION (SOLUTIONS)

1. simple solution - by dissolving solute in a suitable

solvent.

Example: NaCl soln, Strong Iodine solution, CaOH soln

2. solution by chemical reaction by reacting two o

more solute with each other in a suitable solvent.


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Example: Aluminum subacetate soln, Magnesium

citrate solution, Sulfurate lime solution

3. solution by distillationfor isolation of volatile oil

4. solution by extraction drug or pharmaceutical

necessities of vegetable or animal origin.

Aka extractives

a. macerationsubmerging solute

Best used for drugs containing little or no

cellular material such as benzoin, aloe and tolu

w/c dissolves almost completely in the

menstruum.

b. percolationusing percolator

c. digestionwith the aid of gentle heat

d. infusionblanching; + hot water

e. decoctionboiling for 15 mins.

#16 SIMPLE SYRUP

SYNONYM: syrupus, sirup, syrup

DESCRIPTION OF FINAL PRODUCT: clear solution of

sucrose in purified water

USE: sweetening agent, sweet vehicle and basis for

many flavored and medicated syrup

CONTAINER: 60 ml flint bottle

Computation:

M Soln = D x V

mass solvent = mass soln- mass solute

vehicle (Water) - * with the mass solvent

PREPARED BY: percolation

REMARKS: loose cotton permit sucrose light flow

freely

Tight cottoninhibits flow of liquid

Filter paperto prevent holing of sugar

#17 CHOCOLATE SYRUP

USE: flavored vehicle to active medicaments or

substance to improve their taste

SYNONYM: Cacao syrup, chocolate fllavored syrup

DESCRIPTION OF FINAL PRODUCT: viscous, dark brown

syrup with the odor and taste of cocoa

CONTAINER: 15 ml amber bottle

PREPAPERED BY: w/ aid of heat

Ingredients:

1.

Cocoa powderflavorant

2.

Sucrose sweetening agent

3.

Liquid glucose

4.

Glycerin humectant (hydrating agent)

preservative

5.

Sodium chloridetaste balancer

6. Vanilin - flavorant

7. Sodium benzoate - preservative

8.

Purified watervehicle

REMARKS:

Cocoa is NMT 12% non-volatile ether soluble

extractives of fats yields syrups having a

minimum tendency to separate.

Sodium benzoate and glycerin are preservatives

added to prevent bacterial and mold growth

because of low concentration of sucrose

(not self-preserving)

Syrup concentrated aqueous solution containing

sugar usually sucrose or any sugar substitute.

Polyols (glycerin or sorbitol) retart crystalliation of

sucrose to increase its solubility.

TYPE OF SYRUP:

1. simple syrup clear, concentrated, sweet, aqueous

hypertonic solution with striations with concentrations

of 85% w/v or 65% w/w (sp gr.: 1.313) for self

preserving characteristics.

2. flavored/ non-medicated syrup - contains aromatic

and pleasantly flavored substances.

Example: chocolate syrup(flavorant), glycyrrhiza syrup

(masks bitter taste of alkaloid)

3. medicated syrup with active ingredient and has

therapeutic efect

Example:Ipecac, FeSO4


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METHODS OF PREPARATION FOR SYRUP

1. solution without aid of heat

ADVANTAGE: for heat sensitive. Avoids heat induced

conversions

DISADVANTAGE: slowest and time consuming method

Example: FeSO4

2. solution with aid of heatfor heat stable only

ADVANTAGE: fast

DISADVANTAGE: excessive heating will cause inversion

of sucrose and form caramelization

tendency to ferment

sweeter

less stable

prone to microbial growth

Example: acacia syrup, cocoa syrup, syrup USP

3. percolationa percolator or a column is being used.

The fluid rate of liquid(water) is controlled or adjusted

to 20 drops/minute using a cotton.

The percolator will allow the passage of water

slowly through the bed of crystalline sucrose

and will eventually dissolve the sugar.

Example: Tolu Balsam, Simple syrup

4. addition of sucrose to a medicated liquid simple

admixture of sugar to a prepared medicated liquid

usually a fluidextract or a tincture.

The syrup prepared through this is not self

preserving.

Prone to microbial growth low concentration

of sucrose.

#18 ACACIA MUCILAGE

SYNONYM: Mucilage of Gum Arabic, Mucilage of Gum

Acacia

DESCRIPTION OF FINAL PRODUCT: thick,viscid,

adhesive liquid with brown color

USE:

Demulcent

Suspending agent

Excipient in making pills and troches

Emulsifying agent for cod liver oil and minera

oil emulsion

CONTAINER: 15 ml flint bottle

REMARKS:

benzoic acidpreservative

must be free from molds or any other indication

of decomposition

it is unstable and prone to decomposition

(+preservative)

SHOULD NEVER BE MADE IN LARGE

QUANTITIES!

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Pharmaceutical Dosage Form Lab prep 6-18