Manufacturing (SAS 6)

SAS 6

Semisolids

refers to therapeutic ointments, creams, sieves, pastes, or other forms of viscous consistency intended for application on the skin

Petrolatum

a complex mixture of semisolids containing hydrocarbon aliphatic, cycle, saturated, unsaturated branch and unbranched in varying proportions

Mineral oil

obtained from petroleum acid; the lower viscosity is more preferred since it is less tacky (sticky)

Hydrocarbon waxes

frequently employed to increase the viscosity of mineral oil to prevent separation from an ointment

Hydrocarbon waxes

paraffin wax and ceresin wax

Oleaginous substances

vegetable oils such as peanut oil, almond oil, sesame oil, and olive oil are glycerides of mixtures of unsaturated fatty acids

Stearic acids

used in water removable creams as an emulsifier to develop a certain consistency in the cream

Stearyl alcohol and cetyl alcohol

used in creams as auxiliary emulsifiers and emollients

Emulsifiers/water soluble soaps

among the first emulsifiers used for semisolid oil in water emulsions

Polyols

used as humectants

Humectants

it prevents drying up and prevents formation of a crust on top of the cream

Insoluble powders

it must be uniformly dispersed throughout the vehicle to assure homogeneity of the product

Petrolatum and white ointment

are typical lipophilic vehicles

Petrolatum

the most commonly used in ointment vehicles because of its consistent blend and neutral characteristics and its ability to spread easily on the skin

Hydrocarbon bases

these vehicles are difficult to wash off and are used as occlusive dressings which produces sensation of warmth

Absorption bases

are hydrophilic mixtures formed by the addition of substances miscible with hydrocarbons and possess polar groups

Absorption base

Lanolin

Absorption base

Mineral oil is added to these bases to reduce tackiness of the base

Water Removable Bases

refers to oil in water emulsions that upon application and rubbing in to the skin, there is little or no visible evidence of its presence

Creams

maybe applied to moist skin lesions since the O/W vehicle tends to absorb any discharge

Water Soluble Bases

are prepared from mixtures of high and low molecular weight polyethylene glycols

Ophthalmic ointments

these vehicles frequently contain of petrolatum, a brand absorption base or a water soluble base

Preservatives

are added to prevent contamination, deterioration, and spoilage by bacteria and molds

5% Tween

inactivates 80% of the total methylparaben present such that higher concentration of the preservative is required

Boric acid

may be used in ophthalmic preparations against bacterial or fungal contamination

Antioxidants

are added to semi solid whenever oxidative deterioration is anticipated

Rheology

the study of the deformation and few of the liquid and semi-solid pharmaceuticals; when subjected to stress line homogenization, tends to deform in shape and flow

Fusion method

anhydrous ointments are manufactured by this process which is dissolving the AI in the melted fats and waxes or in the vehicle and then mixed with the base

Suppositories

a medicated solid dosage form generally intended for use in the rectum, vagina, and the urethra

Rectal and urethral suppositories

usually employ vehicles that melt or soften at body temperature

Vaginal suppositories

sometimes called pessaries and are made as compressed tablets that disintegrate in the body fluids

Rectal suppository

intended for local action and are most frequently used to relieve constipation or the pain, irritation, itching, and inflammation associated with hemorrhoids or other anorectal conditions

Glycerin suppository

commonly used to promote laxation by local irritation of the mucous membranes

Vaginal suppositories

commonly used as contraceptives, antiseptics in feminine hygiene and agents to combat specific invading pathogen

Urethral suppositories

commonly used as antibacterial or local anesthetic preparative for local examination

Prochlorperazine and chlorpromazine

a rectal preparation used for the relief of nausea and vomiting and as a tranquilizer

Morphine and oxymorphone

a rectal preparation used for opioid analgesia

Ergotamine tartrate

a rectal preparation used for the relief of migraine syndrome

Indomethacin

a nonsteroidal anti-inflammatory analgesic and antipyretic rectal preparation

Ondansetron

a rectal preparation used for the relief of nausea and vomiting

Solid-fat Index (SFI)

a measure of the percentage of fat in crystalline (solid) phase to total fat across a temperature gradient

Hydroxyl value

a measure of unesterified positions on a glyceride molecules and reflects the monoglyceride and diglyceride content of a fatty base

Hydroxyl value

the number represents the milligrams of KOH that would neutralize the acetic acid used to acetylate 1g of fat

Solidification point

this value allows prediction of the time required for solidifying the base when it is chilled in the mold

Saponification value

the number of milligrams of potassium hydroxide required to neutralize the free acids and saponify the esters contained in 1g of fat

Iodine value

this value expresses the number of grams of iodine that reacts with 100g of fat or other unsaturated material

Water number

the amount of water in grams that can be incorporated in 100g of fat is expressed by this value

Acid value

the number of milligrams of KOH required to neutralize the free acid in 1g of substance is expressed by this value

Fatty or Oleaginous Base

most frequently employed suppository base

Cocoa butter, NF

most common base used for rectal suppositories and appears to be the superior base because of its emollient or soothing, and spreading action

Fattibase

made from triglycerides from palm, palm kernel, and coconut oil

Wecobee

made from triglycerides derived from coconut oil

Witepsol

made from triglycerides of saturated fatty acids C12-C18