dds lab

Active Ingredients or Active Pharmaceutical Ingredients (API)

Any component of a drug product intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans or other animals.

Component

Any ingredient used in the manufacture of a drug product including those that may be present in the finished product.

Drug Product

A finished form that contains an active drug and inactive ingredients.

Inactive Ingredient

Any component other than the active ingredients in a drug product.

Batch

A specific quantity of a drug of uniform specified quality produced according to a single manufacturing order during the same cycle of manufacture.

Batchwise Control

The use of validated in-process sampling and testing methods in such a way that it assures that the process has done what it reports to do for the specific batch concerned.

Lot

A batch or any portion of a batch having uniform specified quality and a distinctive identifying lot number.

Lot Number, Control Number or Batch Number

Any distinctive combination of letters or symbols from which the complete history of the manufacture, processing, packaging, handling or storage of a batch or lot of a drug product may be determined.

Product Line Extensions

Are dosage forms in which the physical form or strength, but not the use or indication, of the product changes is usually performed during phase I.

Special Drug Products

Are existing drug products that are developed as new delivery system or for a new therapeutic indication.

Dosage

The quantity of an active agent (substance or radiation) taken in or absorbed at any one time.

Dosage Form (DF)

The physical form of a dose of a chemical compound used as a drug or medication intended for administration or consumption.

Shelf Life

It is that length of time that food, drink, medicine and other perishable items are given before they are considered unsuitable for sale or consumption.

Stability

It refers to the maintenance of the original, physical, chemical and therapeutic properties over an extended period of time or until expiry date.

Physical Stability

Is when each physical property including appearance, palatability, uniformity, dissolution and suspendability are retained.

Chemical Stability

Is when each active ingredients retain its chemical growth in accordance to specified measurements.

Microbiological Stability

Is when the sterility or resistance to microbial growth in accordance to specified measurements.

Therapeutic Stability

Refers to the maintenance of the therapeutic properties of the drug over time.

Toxicological Stability

Refers to the maintenance of the toxicological properties of the drug over time.

Strength

The concentration of a drug substance in a formulation and potency.

Containers

According to USP and NF, it is or may be in direct contact with the drug.

Immediate Container

It is that which is in direct contact with the drug of all times. The closure is part of the immediate container.

Single Dose Container

Its intended to contain a single dose, opened and the contents are used as a single portion.

Multiple Dose Container

A container that permits more than one dose to be withdrawn.

Dripper Bottle

For dispensing ophthalmic, nasal, otic and oral liquid to be administered by drops.

Applicator Bottle

Used for applying liquid medication to a wound or skin surface.

Sifter-top Containers

Used for powders to be applied by sprinkle.

Hinged or Slide Boxes

Used for dispensing powdered preparations prepared in packets.

Aerosol Containers

Used for aerosol products.

Granules

An agglomeration of powder particles.

Tablet

Pharmaceutical dosage forms containing drug substances with or without suitable excipients and prepared either by compression or molding.

Compression Coated Tablets

Are prepared by compressing additional granulation over a previous compressed granulation. This operation may be repeated to produce multilayered tablets of two or three layers.

Dry Coated Tablet

Also referred to as press-coated, are prepared by feeding previously compressed tablets into a special tableting machine and compressing another granulation layer around the preformed tablets.

Layered Tablets

Are tablets composed of two or more layers of ingredients. Layered tablets are prepared by compressing additional granulation onto a previously compressed granulation to form two-layered or three-layered tablets, depending on the number of separate fills.

Delayed Action Tablets

Are tablets that release of the drug is prevented for an interval of time or until certain physiological actions exist.

Repeat Action Tablets

Are controlled release tablets which periodically release a dose of the drug into the gastrointestinal fluids.

Targeted-Release Dosage Forms

Drug delivery systems designed to deliver the drug to a specific site.

First-Order Targeting

Drug is delivered to the site of the capillary bed.

Second-Order Targeting

Drug is delivered to a special cell type, e.g. tumor cells.

Third-Order Targeting

Drug is delivered to intracellular space of the cells.

Coated Tablets

Compressed tablets with a coating that may cover up objectionable tastes or odors and protect materials sensitive to oxidation.

Chewable Tablet

Are big sized tablets which are difficult to swallow and thus, are chewed within the buccal cavity prior to swallowing.

Sublingual Tablet

Are those that are placed under the tongue. It dissolves rapidly and the drug substances are rapidly absorbed by this form of administration.

Troches/Lozenges

Are disk-shaped solid dosage forms containing a medicinal agent and a flavoring agent and are intended to be slowly dissolved in the oral cavity or mouth for local effects.

Dental Cones

Are designed to be placed in the empty socket following a tooth extraction. It is formulated to dissolve slowly in the presence of a small volume of serum/fluid over 20 or 40 minutes period.

Effervescent Tablet

Prepared by compressing granular effervescent salts or other materials having the capacity to release gas (CO2) when in contact with water. Alkaline agents in tablets are frequently added to encourage fast disintegration and solution when added to water.

Dispensing Tablets

Are soft soluble tablets and were used for the preparation of solutions.

Diluents/Fillers

Used to promote cohesiveness and are used to increase the bulk of the tablet.

Examples of Diluents

Microcrystalline cellulose; powdered sugar; calcium phosphate.

Lubricants

Reduce friction that occurs between the tablet and the die.

Examples of Lubricants

Magnesium stearate; calcium stearate.

Flavoring Agents

Used to give a pleasant taste and mask unpleasant taste.

Examples of Flavoring Agents

Saccharin; aspartame.

Adsorbents

Used to hold quantities of liquids.

Examples of Adsorbents

Magnesium oxide; magnesium carbonate; bentonite; silicon dioxide.

Methods of Tablet Preparation

Direct compression method; wet granulation method; molded tablets.

Direct Compression Method

The ingredients in the formulation are intimately mixed and compressed on heavy-duty tablet machines. The material is ground to a uniform size and compressed into the finished tablet.

Wet Granulation Method

This method has more operational manipulations and is more time-consuming than the other methods. The wet granulation method is suitable for drugs which require liquid binders.

Disadvantages of Wet Granulation

1. Involves several steps. 2. Requires longer processing time. 3. Labor costs high.

Molded Tablets

Molded tablets are generally prepared by molding the ingredients with dextrose, mannitol, or some other appropriate diluent.

Picking

The removal of material from the surface of the tablet.

Mottling

The unequal distribution of color on the tablet.

Hardness

The resistance of the tablet to breaking.

Dissolution Rate

The rate at which the tablet dissolves.

Friability

The ability of the tablet to withstand abrasion.

Disintegration

The process by which the tablet breaks apart.

Pill-Splitters

Devices used to cut unscored pills into halves or quarters.

Compressed Pills

Prepared by compression.

Dispensing Pills

Prepared by hand rolling.

Classes of Pills According to Weight

1. Granules (small pills): 20 mg and less; 2. Granules: 20 mg to 60 mg; 3. Pill: 60 mg to 500 mg; 4. Boluses (big pills): 500 mg to 2000 mg.

Suppositories

Are employed for rectal, vaginal, nasal, urethral and aural use.

Suppository Bases

Play an important role in the release of the medication they hold and therefore in the availability of the drug for absorption for systemic effects or for localized effects.

Classification of Suppository Bases

1. Fatty or oleaginous bases; 2. Water-soluble and water-miscible bases; 3. Miscellaneous bases.

Requirements of a Good Suppository Base

Should dissolve rapidly; non-irritating; inert.

Colors and Dyes

Used to disguise off-color dry substances and provide product identification.

Adsorbents

Used as dry powders adsorbed in hydrous oxide.

Anti-Adherents

Reduce sticking or adhesion of the tablet granulation or powder to the faces of the punch and the die walls.

Glidants

Promote the flow of the tablet granulation or powders by reducing friction among particles.

Storage — Cold

2°C to 8°C (36°F to 46°F).

Storage — Freezer

−10°C to −20°C (14°F to −4°F).

Storage — Cool

8°C to 25°C (46°F to 50°F).

Storage — Warm

30°C to 40°C (86°F to 104°F).

Storage — Excessive Heat

Above 40°C (Above 104°F).

Storage — Controlled Room Temperature

15°C to 30°C (59°F to 86°F).

Powdered Medicinals

Are single doses of powdered medicinals individually wrapped in cellophane, metallic foil, or paper.

Coarse Powder

Particle size: 355–1000 microns.

Moderately Coarse Powder

Particle size: 180–355 microns.

Fine Powder

Particle size: 125–180 microns.

Very Fine Powder

Particle size: 90–125 microns.

Type I – Borosilicate glass

High chemical and thermal resistance; used for most pharmaceutical/laboratory applications.

Type II – Treated soda-lime glass

High hydrolytic resistance due to surface treatment; commonly used for aqueous pharmaceutical preparations.

Type III – Soda-lime glass

Moderate hydrolytic resistance; used for dry powders, non-aqueous products, and some oral preparations.

Type IV – General-purpose soda-lime glass

Low hydrolytic resistance; generally used for non-parenteral products and laboratory purposes.

Waxed paper

Packaging ointments, creams, and powders; resistant to moisture and grease

Glassine paper

Packaging powders and tablets/capsules; smooth, dense, and resistant to grease

Kraft paper

Used for wrapping and outer packaging; strong and durable

Parchment paper

Used for wrapping powders and greasy substances; resistant to moisture and grease

Vegetable parchment

Used for packaging products requiring protection from moisture and grease

Greaseproof paper

Used for greasy or oily preparations; prevents absorption of oils and fats

White paper

Dry solids