MOD 3: BIOLOGICAL AND PHARMACEUTICAL IMPORTANCE Flashcards
- having VERY LITTLE or NO THERAPEUTICAL VALUE but are necessary in the manufacture of various dosage forms
- should be of same quality as therapeutic agent
- PHARMACEUTICAL NECESSITIES
- may be required for such purposes as; excipient, preservations, stabilization, acidification, alkalization, etc.
PHARMACEUTICAL AIDS
a part of a drug product ASIDE from the ACTIVE INGREDIENT
EXCIPIENT
- for ANALYTICAL PURPOSES
- as BUFFER systems
- to DISSOLVE insoluble medicinals
- preparation of EFFERVESCENT MIXTURES (render oral drugs more palatable)
ACIDS AND BASES
sol for LIDOCAINE HCl Inj. USP
LIDOCAINE + HCl
sol for NIACIN inj. USP
NIACIN + NaOH
base
source of CO2
SODIUM BICARBONATE
citric acid
tartaric acid
sodium dihydrogen phosphate
ACIDS
3 theories that acids and bases can be defined
ARRHENIUS
BRONSTED-LOWRY
LEWIS
it involves the hydrogen
- formation / production of hydrogen
- liberates H+
ARRHENIUS ACID
produce HYDROXIDE ions
ARRHENIUS BASE
- PROTON
- DONATES hydrogen
- a substance that can DONATE PROTON
BRONSTED-LOWRY ACID
- PROTON
- ACCEPTS hydrogen
- a substance that can ACCEPT PROTON
BRONSTED-LOWRY BASE
electron pair ACCEPTOR
LEWIS ACID
electron pair DONOR
LEWIS BASE
35-38% (w/w) HCl
HYDROCHLORIC ACID USP
- Hydrochloric acid USP
- Diluted Hydrochloric acid USP
- Arsenious acid
- Nitrohydrochloric acid
HYDROCHLORIC ACID
9.5-10.5% (w/w) HCl
- treatment of GASTRIC ACHLORYDRIA (lack of HCl)
DILUTED HYDROCHLORIC ACID USP
lack of HCl
GASTRIC ACHLORHYDRIA
- ARSENIC CHLORIDE SOLUTION
- HCl converts arsenic trioxide to arsenic trichloride
ARSENIOUS ACID
- NITROMURIATIC ACID
- AQUA REGIA - kingly water
- in diluted form: activates PEPSIN
NITROHYDROCHLORIC ACID
KINGLY WATER
AQUA REGIA
mixture of acid that can DISSOLVE GOLD
AQUA REGIA
enzyme that can digest proteins
PEPSIN
- EAU FORTE
- AQUA FORTIS - strong water
- used in manufacture of EXPLOSIVES, nitrates
- Ferric subsulfate solution
- Mercuric nitrate solution
- Bismuth magma
NITRIC ACID
- MONSEL’S SOLUTION
- nitric acid oxidizes ferrous ion to ferric ion
FERRIC SUBSULFATE SOLUTION
- nitric acid converts BISMUTH SUBNITRATE to nitrate
BISMUTH MAGMA
- Phosphoric acid USP
- Diluted Phosphoric acid USP
PHOSPHORIC ACID
85-88% (w/w) H3PO4
PHOSPHORIC ACID USP
9.5-10.5% (w/) H3PO4
DILUTED PHOSPHORIC ACID USP
- Sulfuric acid USP
- Saccharated Ferrous carbonate
SULFURIC ACID
94-98% (w/w) H2SO4
SULFURIC ACID USP
diluted H2SO4 as ACIDIFIER
SACCHARATED FERROUS CARBONATE
- Kaolin cataplasm
- Boric acid solution
- Boric acid ointment
- Lister’s solution
- Compound zinc sulfate powder
BORIC ACID
ANTISEPTIC SOLUTION
LISTER’S SOLUTION
ANTISEPTIC POWDER
COMPOUND ZINC SULFATE POWDER
used as STANDARD SOLUTION in ACID-BASE TITRATION
SODIUM HYDROXIDE
similar no NaOH but MORE DELIQUESCENT, STRONGER AND MORE EXPENSIVE than NAOH
POTASSIUM HYDROXIDE
- HYDRATED LIME / SLAKED LIME
- mixed with 3-4x of water: MILK OF LIME
- saturated aqueous solution: LIME WATER
- antacid
- mild astringent
- saponifying agent for oils
CALCIUM HYDROXIDE
CALCIUM HYDROXIDE mixed with 3-4x water
MILK OF LIME
CALCIUM HYDROXIDE saturated aqueous solution
LIME WATER
- anhydrous: SODA ASH
- decahydrate: SAL SODA, WASHING SODA
- as anhydrous: BUFFER preparations
- as solution: LOTION preparations
SODIUM CARBONATE
SODIUM CARBONATE anhydrous
SODA ASH
SODIUM CARBONATE as decahydrate
SAL SODA, WASHING SODA
SODIUM CARBONATE as anhydrous
BUFFER PREP
SODIUM CARBONATE as solution
LOTION PREP
- STRONGER ammonia water
- 27-29% NH3
- used in manufacture of ammonium salts, nitric acid, fertilizers
STRONG AMMONIA SOLUTION
- AMMONIA WATER
- 9-10% NH3
- Spirit of Hartshorn: product of destructive distillation of HORNS OF MALE DEER
- Household ammonia: for CLEANING and WASHING due to water softening and saponifying properties
DILUTED AMMONIA SOLUTION
ability of substance to ABSORB MOISTURE in air and DISSOLVE it
DELIQUESCENT
ability to JUST ABSORB moisture in air
HYGROSCOPIC
- are compounds or mixture of compounds, that by the presence in solution, RESIST PH CHANGES upon addition of SMALL QUANTITIES of acid or alkali
- MAINTAIN the pH of medicinals at optimal limits
BUFFERS
measure of acidity or basicity
pH
LOWER pH
ACIDIC
HIGHER pH
BASIC
- salts of SOIUM PHOSPHATE + NaCl (pH 6-8)
- a.k.a. PHOSPHATE BUFFERED SALINE (PBS)
SORENSEN PHOSPHATE BUFFER
pH level of SORENSEN PHOSPHATE BUFFER
6-8
SORENSEN PHOSPHATE BUFFER mixture
SALTS OF SODIUM PHOSPHATE + NaCl
boric acid + sodium bicarbonate + KCl (pH 5-9)
GIFFORD’S BUFFER
GIFFORD’S BUFFER mixture
BORIC ACID + SODIUM BICARBONATE + KCl
pH level of GIFFORD’S BUFFER
5-9
boric acid + sodium carbonate + NaCl
ATKIN’S AND PANTIN BUFFER
ATKIN’S AND PANTIN BUFFER mixture
BORIC ACID + SODIUM CARBONATE + NaCl
boric acid + sodium borate + NaCl
FELDMAN’S BUFFER / PALITZSCH BUFFER
FELDMAN’S BUFFER / PALITZSCH BUFFER mixture
BORIC ACID + SODIUM BORATE + NaCl
frequently used in formulation of OPTHALMIC SOLUTIONS
PHARMACEUTICAL BUFFERS
widely used as:
- raw material
- inactive ingredient
- medicinal vehicle
- solvent
- processing, formulation, and manufacture of pharmaceutical products (dosage forms), active pharmaceutical ingredients (APIs) API intermediates, compendial articles, and analytical reagents as well as in cleaning applications
WATER
- contain varying amounts of suspended matter, such as clay, sand, microorganisms, and fragments of plants and animals
- MINERAL WATERS, NATURAL SPRING WATERS, WELL WATERS
NATURAL WATERS
w/ Na and Mg sulfates + NaHCO3
ALKALINE WATER
charged with CO2 under pressure
CARBONATED WATER
w/ iron characterized by FERRUGINOUS TASTE
CHALYBEATE WATER
w/ LITHIUM carbonates or chlorides
LITHIA WATER
- PURGATIVE WATER
- w/ Na and Mg sulfates + NaCl
SALINE WATER
w/ HYDROGEN SULFIDE
SULFUR WATER
w/ ALKALI SILICATES
SILICEOUS WATER
water can be characterized by
HARDNESS
- presence of SOLUBLE Ca and Mg BICARBONATES
- can be softened by BOILING or LIME PROCESS
TEMPORARY HARDNESS
- presence of INSOLUBLE Ca and Mg CHLORIDES AND SULFATES
PERMANENT HARDNESS
are typically produced ON-SITE where they are used
BULK MONOGRAPHED WATERS
- as EXCIPIENTin the production of NONPARENTERAL preparations and in other pharmaceutical applications
- NOT introduced directly into the bloodstream
- NOT required to be sterile
- WATER OF CHOICE for extemporaneous compounding
PURIFIED WATER
absence of microbes
STERILE
a drug or mixture of drugs prepared or compounded in a pharmacy according to the order of a prescriber
EXTEMPORANEOUS COMPOUNDING
- as excipient in the production of PARENTERAL and other preparations where product ENDOTOXIN content must be CONTROLLED, and in other pharmaceutical applications
- minimal quality of source water: DRINKING WATER
- NOT required to be sterile
WATER FOR INJECTION
- for HEMODIALYSIS applications
- minimal quality of source water: DRINKING WATER
WATER FOR HEMODIALYSIS
- CLEAN STEAM
- porous load STERALIZATION PROCESSES product or cleaning solutions heated by direct steam injection, or humidification of processes where steam injection is used to control the humidity inside processing vessels where the official articles or their in-process forms are exposed
PURE STEAM
these are produced, packaged, and sterilized to preserve microbial quality throughout their packaged shelf life
STERILE MONOGRAPHED WATERS / STERILE WATERS
- PURIFIED WATER, packaged and rendered sterile
STERILE PURIFIED WATER
- WATER FOR INJECTION packaged and rendered sterile
- for extemporaneous prescription compounding and as sterile diluent for parenteral products
- packaged in single-dose containers NMT 1L
STERILE WATER FOR INJECTION
- water for injection, packaged and rendered sterile, to which has been added one or more suitable ANTIMICROBIAL PRESERVATIVES (e.g. benzyl alcohol)
- intended to be used as a diluent in the preparation of parenteral products, most typically for MULTI-DOSE products that require repeated content withdrawals
- packaged in single-dose or multiple-dose containers NMT 30mL
BACTERIOSTATIC WATER FOR INJECTION
- water for injection packaged and sterilized
- in SINGLE-DOSE containers that MAY BE LARGER THAN 1L and allow RAPID DELIVERY of their contents
STERILE WATER FOR IRRIGATION
- WFI that is packaged and rendered sterile
- intended for use in INHALATORS and in the preparation of INHALATION SOLUTIONS
STERILE WATER FOR INHALATION
- POTABLE WATER (drinkable or fit to drink)
- prescribed SOURCE OF FEED WATER for the production of bulk monographed pharmaceutical waters
DRINKING WATER
- purified water that has been VIGOROUSLY BOILED for NLT 5min, then cooled and protected from absorption of atmospheric carbon dioxide
CARBON DIOXIDE-FREE WATER
- produced by VAPORIZING DRINKING WATER or a higher quality of water and condensing it into a PURER STATE
DISTILLED WATER
- produced by an ion-exchange process in which the cations and anions are replaced with H+ and OH- ions by use of ION-EXCHANGE RESINS
DEIONIZED WATER
intended to come into DIRECT CONTACT with pharmaceutical products
GLASS CONTAINERS
- DECREASES coefficient of expansion in Pyrex glass
BORON
- provide AMBER LIKE light resistant glass
POTASSIUM
- INCREASE REFRACTIVE INDEX
LEAD
- NEUTRAL GLASS
- suitable for most products for parenteral and nonparenteral uses
TYPE 1 (BOROSILICATE GLASS)
TREATED SODA LIME GLASS
- suitable for most ACIDIC and NEUTRAL aqueous products for parenteral and nonparenteral uses
TYPE II (TREATED SODA-LIME-SILICA)
REGULAR SODA LIME GLASS
- NOT USED FOR PARENTERAL PRODUCTS or for powders for parenteral use
TYPE III (SODA-LIME-SILICA)
used to DIFFERENTIATE the TYPE OF GLASS
GLASS GRAINS TEST
GENERAL PURPOSE SODA LIME GLASS
- for TOPICAL and ORAL dosage forms
TYPE IV (NP GLASS)
used to REDUCE the OXIDATION of ACTIVE SUBSTANCES and excipients in the finished product
ANTIOXIDANTS