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Medicinus - Dexa Medica

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dosage and the effectiveness of a drug describes as<br />

its biological activity in animals or in men. Both safety<br />

and effectiveness are primarily a quality of drug<br />

substance to show that they are not of prime interest<br />

within the scope of pharmaceutical technology. Acceptability<br />

of a drug is a more complex notion since<br />

it comprises both properties which make it easier to<br />

take a medicine, such as its taste, its smell, its appearance<br />

and qualities contamination. 1<br />

DOSAgE FORM DESIgN<br />

Drug substances are seldom administered alone,<br />

but rather as part of formulation in combination<br />

with one or more nonmedical agents that serve<br />

varied and specialized pharmaceutical functions<br />

referred to pharmaceutical ingredients. The functions<br />

of pharmaceutics’ ingredients may be served<br />

as: filler, binder, desintegrant, glidant, lubricant, anti<br />

adherant, solubilize, suspend, thicken, dilute, emulsify,<br />

stabilize, preserve, color, flavor, etc.<br />

The proper design and formulation of a dosage<br />

form requires consideration of the physical, chemical<br />

and biological characteristics both of the drug substances<br />

and pharmaceutical ingredients to be used in<br />

fabricating the product. The drug and pharmaceutical<br />

material utilized must be compatible with one another<br />

to produce a dosage forms product that is safe,<br />

effective and acceptable. Dosage forms are needed<br />

for many reasons as follows:<br />

1. For the protection of a drug substance from the<br />

destructive influences of atmospheric oxygen or<br />

humidity<br />

2. For the protection of a drug substance from destructive<br />

influence of gastric acid after oral administration<br />

3. To conceal the bitter, salty, or offensive taste or<br />

odor of a drug substance<br />

4. To provide liquid preparations of substances that<br />

are either insoluble or unstable in the desired vehicle<br />

5. To provide clear liquid dosage forms of substances<br />

6. To provide time-controlled drug action<br />

7. To provide optimal drug action from topical administration<br />

sites<br />

8. To provide for the insertion of a drug into one of<br />

the body’s orifices<br />

9. To provide for the placement of drugs directly<br />

into bloodstream or into body tissues<br />

10. To provide for optimal drug action through inhalation<br />

therapy.<br />

Before formulating a drug substance into dosage<br />

form, it is important to predetermine the desired<br />

technology<br />

product type insofar as possible in order to establish<br />

the framework for product development. Most<br />

commonly, a pharmaceutical manufacturer prepares<br />

a drug substance in several dosage forms and<br />

strengths for the efficacious and convenient treatment<br />

disease. The formulation of modern drug that<br />

best meet the goals for the product, normally consist<br />

of one active substance in combination with one or<br />

more pharmaceutical ingredients , and there are several<br />

dosage forms into which a combination active<br />

substances are needed. 2<br />

Active substance should be checked for identity,<br />

purity and potency, prescription for which can be<br />

found in pharmacopoeias or comparable compendia.<br />

Sometimes these prescriptions have to be completed<br />

with specific ones when special requirements<br />

have to be set for the preparations to be made of<br />

these.<br />

Modern drug treatment uses preparations that<br />

are frequently prepared by manufacturer and which<br />

require no further manipulation in the pharmacy.<br />

Most modern drugs are available in tablets, capsules<br />

or injections. The efficacy of the drug in the body depends<br />

on the dose of active substance. The dose of<br />

a drug has been appropriately described as amount<br />

which is “enough but not too much”, the idea being<br />

to produce the drug’s optimum therapeutic effect<br />

in a particular patient with the lowest possible dose.<br />

The dose of a given drug is specific to the patient,<br />

with many factors contributing to its size and effectiveness.<br />

Table 1 presents examples of some drugs<br />

with relatively low usual doses.<br />

Table 1. Examples of some drugs with relatively low<br />

usual doses 3<br />

No. Drug Usual<br />

dose<br />

(mg)<br />

Category<br />

1 Lithium carbonate 300 Antidepressant<br />

2 Ferrous sulfate 300 Hematinic<br />

3 Cimetidine 300 Antiulcer<br />

4 Ibuprofen 300 Antiinflamatory<br />

5 Amoxicillin 250 Antibacterial<br />

6 Erithromycin 250 Antibacterial<br />

7 Nitrofurantoin 100 Antibacterial<br />

8 Propoxyphene HCl 65 Analgesic<br />

9 Hidrochlorothia-zide 50 Diuretic<br />

10 Codeine phosphate 30 Analgesic<br />

11 Phenobarbital 30 Sedative<br />

12 Diphenhydramine<br />

HCl<br />

25 Antihistaminic<br />

MEDICINUS 24(1), January 2011 35

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