Schedules Drugs

Schedules Drugs

Creams – semisolid emulsion systems (o/w, w/o) containing more than 10% of water.

Pastes – semisolid dispersion system, where a solid particles (> 25%, e.g. ZnO) are dispersed in ointments – mostly oleaginous (Petrolatum).

Schedule I

Drugs in this schedule have a high abuse potential (narcotic and hallucination effects). Examples are heroin, marijuana.

Schedule II

Drugs in this schedule have a high abuse potential with severe psychic or physical dependence liability. Included are certain narcotic analgesics, stimulants, and depressant drugs. Examples are opium, morphine, codeine, hydromorphone, methadone, meperidine, oxycodone, anileridine, cocaine, amphetamine, methamphetamine, phenmetrazine, methylphenidate, amobarbital, pentobarbital, secobarbital, methaqualone, and phencyclidine.

Schedule III

Drugs in this schedule have an abuse potential less than those in Schedules I and II and include compounds containing limited quantities of certain narcotic analgesic drugs, and other drugs such as barbiturates, glutethimide, methyprylon, and chlorphentemine. Any suppository dosage form containing amobarbital, secobarbital, or pentobarbital is in this schedule.

Schedule IV

Drugs in this schedule have an abuse potential less than those listed in Schedule III and include such drugs as barbital, phenobarbital, chloral hydrate, ethchlorvynol, meprobabmate, chlordizepoxide, diazepam, oxazepam, chloroazepate, flurazepam, etc.

Schedule V

lDrugs in this schedule have an abuse potential less than those listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotic analgesic drugs used for antitussive and antidiarrheal purposes.

Antioxidants which act by providing electrons and easily available hydrogen atoms that acceptable more readily by the free radicals (atoms containing one or more unpaired electrons as molecular oxygen O-O or free hydroxyl group (OH)

Examples of Antioxidants: Na2SO3 , NaHSO3, H3PO2  and Ascorbic

In oligeanous preparation - alpha tocopherol, BHA (butylhydroxyanisole), BHT (butyl hydroxytoluene) and ascorbyl palmitate.

EXAMPLES:

Epinephrine preparations - Adrenergic - do not use the if it is brown or contains precipitate

Nitroglycerin Tablets - Antianginal - to prevent loss of potency, keep these tablets in the original container

Paraldehyde - Hypnotic - subject to oxidation to form acetic acid.

Polymorphism:

@ important factor on formulation is the crystal or amorphous from of the drug substance.

@ the amorphous form of a compound is always more soluble than a corresponding crystal form.

@ the most widely used methods are hot stage microscopy, thermal analysis,infrared spectroscopy, and x-ray diffraction.

Q10 Method of Shelf Life Estimation

@ estimate shelf life for a product that has been stored or is going     to be stored under a different set of conditions.

Probable Modes Of Action Of Some Preservatives

1.  Benzoic acid, boric acid, p-hydroxybenzoates: Denaturation of proteins.

2.  Phenols, chlorinated phenolic cmpds: lytic, denaturation action on cytoplasmic membranes and for chlorinated preservatives, also by oxidation of enzymes

3.  Alcohols:  lytic and denaturation action on membranes.

Quaternary compounds:  Lytic action on membranes.

4.  Mercurials:  Denaturation of enzymes by combining with thiol (-SH) groups.

Flavoring Agents

*** To mask effectively the unwanted or disagreeable taste of drugs

In general, low molecular weight are salty, like NaCl, KCl, NH4Cl, NaBr and higher molecular salts are bitter except some lead salts.

Examples:  Anise oil, Cinnamon, Peppermint, and Orange.

With organic compounds, an increase in the number of OH group seems to increase the sweetness of the compound.  Sucrose which has 8 OH groups is sweeter than glycerin which has 3 OH groups.

Sweetening Pharmaceuticals

Saccharin = metabolized and excreted by the kidneys virtually unchanged.

Cyclamate = metabolized or processed in digestive tract and its by product are excreted by the kidneys.

Aspartame = breaks down in the body into three basic components: the amino acids phenylalanine and aspartic acid, and methanol.

@ because of its metabolism to phenylalanine, the use of aspartame by persons with phenylketonuria (PKU) is discourages, and diet foods and drinks must bear appropriate label warning.

@ saccharin and cyclamate were “generally recognized as safe” or what is known as GRAS.

Acesulfame = is more stable than aspartame at elevated temperature; it is use in candy, chewing gum, confectionery, and instant coffees and teas.

Stevia powder = Stevia rebaudiana bertoni.  It is natural, nontoxic, safe, and about 30 times as sweet as cane sugar, or sucrose.

AESTHETIC VALUE

     Liquid preparations - the amount is ranging from 0.0005 to 0.001% depending upon the colorant and intensity desired

     Solid or powdered, Compressed Tablets - generally larger proportion is required (0.1%)

     Ointments, suppositories, opthalmic and parenteral -no color additives