Dose Form Exam II Definitions
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Solid dosage Form prepared by compression or molding of powdered/granulated drugs and with the aid o suitable pharmaceutical excipients
What are some characteristics of tablets?
- Stable, elegant, effective
- Convenient for handling, identification and adminisration
- Many formats, sizes, colors, shapes, scored in halves with elegant engravings
- Multi Compressed
- Sugar Coated
- Film Coated
- Gelatin Coated
- Enteric Coated
- Lozenges,Trochs, Drops, Pastilles
- Tablet Triturates
- Rapid Dissolving
- Extended Release
- Vaginal Tablets
Single compression of all ingredients
Multiple Compressed Tablets
For separation of incompatiple drugs or for modified release
Multple Layered Tablets
- Multiple Compressed Tablets
- Multiple feed and multiple compression of fill within a single die
Tablet within a Tablet
Core tablet is placed prescisly within the die for compression with surrounding fill
Sugar Coated Tablet
- Several layers of color or uncolored sugar solution (sucrose, gelatin, acacia or PVP = polyvinylpyrrolidone)
- Final tablet increased of up to 50% of size and weight if uncoated tablet
- Final tumbling with talc for high luster
Product specific indentification codes and distinctive symbols
Cloth or canvas impregnated with carnauba wax, bees wax or spraying with wax dissolved in acetone
Film coated Tablet
- Thin layer of aqueous or non-aqueous polymer (plastic like material) cellulose acetate phthalate cellulose ether polymers
- Protection, color, durability less bulkiness, less time consuming
Gelatin Coated Tablets
- Capsule-shaped compressed tablets coated with gelatin
Enteric Coated Tablets
- Protection of drug against patient gastric mucosa or enhanced absorption
- Based on transit time required for the passage of the dosage form from the stomach into the intestines or based upon the pH of environment
- Delayed release action
- Materials; shellac, phthalate derivatives
Placed in cheek pouch to dissolve slowly, absorption through the oral mucosa
Placed under the tongue, for prompt dissolution and absorption thoughout the oral mucosa
- Chewed and dissolve in the mouth made with creamy base (mannitiol, sorbitol, xylitol=sugar free)
- Negative heat of solution leaves a cool mouth feeling upon dissolution
- Flavored and colored
- For children and adults who have difficulty swallowing
Lozenges, Troches, Drops, Pastilles
- Hard candy like (sugar of sugar free) or gummy like (gelatin base)
- Dissolve or distintegrate slowly in the oral cavity
- Heat stable active ingredients
- Local effects
- Sugar based lozenge on a stick (also sugar based)
- Compression of effervescent salts that liberate carbon dioxide when dissolved in water
- Should not be swallowed whole
MOlding and salts compaction , hand operated tablet press
"Old Fashioned" tablet containing small amounts of potent drugs and prepared with minimal compression to allow ease of crushing for compounding and rapid dissolution
Rapid Dissolving Tablets
- SUPER DISINTEGRANTS
- Dissolution within 15 to 30 seconds
- Very water soluable excipients that attract water into the tablet
What are some inherent problems with Rapid Dissolving Tablets?
Drug loading, taste masking and friability
Extended Release Tablets
Release of medication in a pre-determined manner over an extended period
- Uncoated, bullet shape or ovoid
- Plastic or cardboard inserter device for administration
- Local Effects
What is the proccess of Wet Granulation
- 1) Weigh and blending of drug. fillers, disintegrating agents. glidants
- 2) Sifting of powder to eliminate clumps
- 3) Mixing with liquid binder/adhensive agent, 10 to 20% aquous/alchoholic solution of corn starch, 25 to 50% solution glucose, molasses, gums such as acacia, solution of cellulose derivatives, gelatin
- 4) Damp mass, damped/ wet powder
- 5) Pass through screen 6 to 8 screen size
- 6) Drying: thermostatically controlled over
- 7) Sizing dry screening 12-20 mesh size
- 8) Blending of granules and lubricants (Mg/Ca/Zn Sterate/Talc/Stearic Acid)
- 9) Compression, tableting machine
What is the Dry granulation proccess?
- For materials that are degraded in the presence of moisture or high heat
- 1) Weighing blending of powdered ingredients, drugs, fillers, disintegrating agents, cohesive properties
- 2) Binding agents are added (methylcellulose/hydroxyl methylcellulose)
- 3) Powders are compressed in slugginh machine
- 4) Slugs crushed and sized
- 5) Granules and dry lubricants (Mg/Ca/Zn Sterate/ Talc)
- 6) Compression in tableting machine
- Excipients have free flowing and cohesive properties
- Potassium chloride, Methenamine, Dibasic Calcium Phosphate
Molding of Tablets
- Forcing of a dampened mass into th cavities of a tablet mold (plastic or metal)
- Mold consists of two plates one with a hole and the other with a peg
- TO remove loose powder
- Prior to coating
- For protection of drug from air and humidity
- To protect gastric mucosa of irritating drugs
- Mask Taste
- To provide aesthetics and distinction to a product (color, imprinting and manufacturer symbol or information)
What are the quality control from the USP?
- Content uniformity
- Hardness, breaking strength, Friability
What is the USP quality control for WEIGHT?
- Weight variation for dosage form uniformity
- Assay for homogenous drug distribution
What is the USP quality control for CONTENT UNIFORMITY?
Active ingrediant between 90 and 110%
What is the USP quality control for HARDNESS BREAKING STRENGTH FRIABILITY?
- Measurement of pressure/force to break each tablet
- Measure the tendency of a tablet to cumble (rotating tubling container)
- Tablet are weight before and after rotation and weight loss is determined (maximum loss allowed by USP is 1%)
What is the USP quality control for THICKNESS?
- Caliper, hand gauge or automated equipment
- Depends on; diameter of the die, amount of the fll, compaction characterisics of fill
- Pressure applied
What is the USP quality control for DISINTEGRATION?
- The time required for a tablet to disintgrate
- Compressed tablets: Aparatus containing water ( 30 mins) at 37oC or simulated gastric fluid (1 hour)
- Enteric Coated: simuated gastric fluid (1 hour) and intestinal fluid at 37oC
What is the USP quality control for DISSOLUTION?
- In vitro testing
- Quality assurance during manufacturing
- Bioequivalence from batch to batch; from the scale up batch
- Madatory for approval for marketing
- Influences the absorption and bioavailability
What are some feature of package and storage for tablets?
- Containers; bottles, blister
- Light resistant
- Desiccant packet and cotton ball
- Type of container: reduced potency of volatile drugs
- Nitroglycerin and no packing materials in catact with tablets
What are the some uses for topical preparations?
- Protection of injured area and rejuvenation of the skin,
- Hydration, Lubrication or emollient effect
How do topical preparations convey medications to the skin or mucosa?
- Specific effect
- Topically or systemically
Where can topical preparation be applied?
Topical Dermalogical Products, definition
Deliver drug INTO the skin (the target) to treat dermal disorders (topical absorption)
Transdermal Products definition
Deliver drug through the skin (percutaneous absorption) to the general circulation for systemic effects (skin is not the target)
What are factors that affect drug penetrations?
- Surface Area
- Condition of the skin
- Base/delivery system used
- Occlusive dressing
What are some features of ointment?
- Semisolid preparation for external application to the skin or mucous membranes.
- Soften or melt at body temperatures
- Spread easily
- Not gritty
Where are ointments applied?
To dry skin scaly lesions, skin mucosa, and eye
What is the composition of ointments?
- Active drugs
- Ointment base (oleaginous, aqueous)
- Stiffeners: viscosity
- Humectants: escape of moisture
- Antioxidants: Rancidfication
- Penetration enhancers: penetration into the skin
- Preservatives: microbial growth
What are the characterisic of an oleaginous base?
- Not water washable
- Insoluable in water
- Will not absorb water
What are some examples of oleaginous base?
- White petrolatum
- White ointment
What are the characterisic of an absorption base?
- Insoluble in water
- Not water washable
- Can absorb water
What are some examples of absorption base?
- Hydrophilic petrolatum
What are the characterisics of W/O emulsion?
- Insoluble in water
- Will absorb water
- Not water washable
- Contain Water
What are some examples of W/O emulsion?
- Cold Cream
- Lanolin, hydrous
What are the characterisics of O/W Emulsion?
- Insoluble in water
- Water washable
- Will absorb water
- Contains Water
- Not occlusive
- Not greasy
What are the characterisics of water soluble ointment base?
- Water soluble
- Water washable
- Will absorb water
- Anhydrous or hydrous
- Not occlusive
- Not greasy
What is an example of a water soluble ointment base?
What kind of skin pentration does epidermic base have?
- None or very little skin penetration
- Type of base used oleaginous
- Refers to the external layer of the skin, epidermis
What kind of skin penetration dose endodermic base have?
- Into the dermis
- Type of base used absorption base
- Refers to the internal layer of the skin, or dermis
What kind of skin penetration dose diadermic base have?
- Yes into the skin and through the skin
- Type of base used emulsion and water soluble base
- Refers going through the skin
What are some factors in selecting the correct ointment base?
- Drug release rate
- Enhancement of percutaneous absorption Occlussion of moisture (If skin is dry wet ir, If it is wet dry it)
- Stability of drug
- Influence on other components of formuation (consistency)
- Patient Factors (dry skin, intact or broken skin)
What are some compounding techniques for incorporation of ointments?
What are the steps for incorporating of solids in an ointment?
- 1) Reduction of particle size
- Levigation, low surface tension to improve wetting, minimum amount
- 2) Incorporation of solids to ointment by geometric method
- 3) Dissolution of solids in small amounts of solvent compatible with the base
- 4) Large volumes of liquids: use mortar pestle
What are the properties of mineral oil as a levigating agent?
- Specific Gravity 0.88
- Misciple with fix oils except for Castor Oil
- Uses; Oleagenous,Absorption, Water in oil emulsion bases
What are the properties of glycerin as a levigating agent?
- Specific Gravity 1.26
- Misciple in water, Alcohol, Proplene glycol, PEG 400
- Imiscible, with mineral and fixed oils
What are the properties of propylene gylcol as a levigating agent?
- Specific gravity 1.04
- Miscible with water alcoholm glycerin and PEG 400
- Immiscible with mineral oil and fixed oils
What are the properties of PEG 400 as a levigating agent?
- Specific gravity 1.13
- Miscible with water, alcohol, and propylene glycol
- Immiscible with mineral oil and fixed oils
What are the properties of Cottonseed oil as a levigating agent?
- Specific Gravity 0.92
- Miscible with mineral oil and other fixed oils, castor oil
- Immiscible with water, alcohol, Glycerin, Propylene Glycol and PEG 400
What are the properties of Castor Oil as a levigating agent?
- Specific Gravity 0.96
- Miscible with Alcohol and fixed oils
- Immiscible with water, Glcerin propylen glycol, PEG 400, mineral oil and fixed oils
What are the properties of Polysorbate 80 as a levigating agent?
- Tween 80
- Specific gravity 1.06-1.09
- Miscible with water, alcohol, glycerin, propylene glycol, peg 400, mineral oil and fixed oils
What is the fusion method of incorporation?
Melting of ingredients together and cooling with constant stirring until congealing
What are the steps involved in fusion method of incorporation?
- 1 Oleaginous phase oils and waxes are melted together
- 2 Aqueous phase: solution of heat stabl and water soluble ingredients are heated to simlar temperatures
- 3 Pouring of aqueous into oily with stirring
- 4 Cooling with frequent stirring until congealing
What are the compendial requirments for microbial content for ointments?
- Not required to be sterile (except for ophthalmics)
- Antimicrobial preservatives
- Rectal urethral and vaginal: tested for yeast and molds
What are the compendial requirements for the use of jars with ointments?
Clear or opaque plastic or glass, colored, sizes range from 0.5 oz to 1 lb
What are the compendial requirements for the use of tubes with ointments
- Greater protection against external contamination and environmental conditions
- PLastic or aluminum coated with epoxy resin, vinyl or lacquer
What are the compendial requirements for the use of storage with ointments
Stored at room temperature, excessive heat will cause softening and separation phases
What are the compendial requirements for the use of labeling with ointments
Need the route of administration and mode of administration
What are some viscosity concerns with ointment and what methods are used to prevent them from happening?
- Change in consistency
- Bleeding of iquid and phase separation: needs levigating agent
- Drying out of ointment: need humectant (glycerin, propylene glycol)
- Oleagenous and anhydrous bases: relatively stable
- Emulsion bases: less stable
What is the definition of a cream?
- Semisolid dosage forms containing one or more drug substances dissolved or dispersed in a suitable base, they possess a relatively fluid consistancy and formulated o/w or w/o emulsion
- Opaque soft solids or very thick liquids for external application
What is an vanishing cream?
Creams of the o/w emulsion type with a large percent of water and stearate soup-type emulsifiers (water evaporates leaving a thin film on the skin)
What are the applications of creams?
- Weeping or oozing lesions
- Drying effect: body fluids miscibl with cream aqueous external phase
What is the definition of a paste?
- Thick stiff ointment that ordinally do not flow at body temperature and have reduced absorption
- To coat the affected area for protection
What are the applications of pastes?
- For areas that require protection remains in place longer than ointments: sticky. Absorption of serious discharge from skin lesions. Less greasy feeling, not suited for hairy parts of skin
- If they are too stiff it is difficult to apply
What is the definition of a Gel?
- Semisolid system consisting of dispersion of small inorganic particles or large organic molecules interpenetrate by a liquid
- Are semisolid systems in shich the moement of the dispering medium is restricted by an interlacking three dimension network of particles
What is the advantage of a gel?
Excellent drug delivery system; oral, topical, nasal, vaginal, rectal, compatible with many different drugs and very efficacious
Taking up of liquid with no measurable increase in volume
Taking up of liquid in volume
Intense interaction between particles of the dispensed phase so that on standing the dispersion medium is squeezed out in droplets and the gel shrinks = instability
Reversible gel-sol formulation with chang in the volume of temperature
Removal of the liquid from a gel leaving only the framework gelatin in sheets, acacia, tears, tragacanth ribbons
What are the characterisics of gel dose form?
- Gels may be as clear as liquid, others are terbid. Ingrediants not completly molecular dispersed or dissolved
- Most gels are water washable, water soluble, water absorbing and greaseless
What is the single phase system for gel?
Gels that contain linear or branched polymer macromolecules, that dissolve in water and have no apparent boundry with the dispersing medium
Single-phase gels made from synthetic or natural macromolecules
What is the two phase system for gel?
Gels that contain small discrete particle
semisolid on standing but liquid when shaken
Are two phase system with large particle size or floccule of small distinct
What are the general guidelines for preparing a gel?
- Active drug does not interfere with the gelling process, add it prior to gelling for uniformly dispersion
- Active drug interferes with gelling process, place gel + active ingredient in a plastic bag, which is kneaded to thoroughly mix the drug, then cut corner of bag
- Gelling agents usually have 0.5 to 2 percent concentration
What is generally the fastest way of dispersion of drug in gel?
Sprinkling slowly very small particles of powder (through a sieve) into a rapid stirring liquid
What is the proccess that removes the bubbles in a gel?
What is a neutralizer in preparing a gel?
thicken the gel after the gelling agent is dispersed
What does a plaster do in a gel?
- Adhesive masses spread on a backing of paper, fabric, moleskin or plastic
- Provide prolonged contact and effect at the site of application
What does glycerogelatins do in a gel?
Plastic masses containing gelatin (15%) glycerin (40%) water (35%) and medicinal ( 10%)
What are some important information about topical dosage forms?
- Banage only if prescribed, open to the atmoshpere whenever possible
- Ointments creams and pastes, should not be substituted one for another by a pharmacist without the consent of the prescribing physcian
What is the definition of a solution?
Liquid preparations that contain one or more chemical substances dissolved in a suitable solvent or mixture of mutally miscible solvents
What are the routes of administration for solutions?
- Vaginal - douches
- Rectal - enemas
- Otic (arual)
What are the aqueous solutions?
- Oral solutions
- Aromatic waters
What are the non-aqueous solutions?
- Other fluid extract
- Oleaginous solutions
What are the advantages of solution as a dose form?
- Homegeneous doses
- Immedient availability
- Most routes of administration
- Easy dose adjustment
- Enteral feeding
- Nursing home, psychiatric and incarerated patients
What are the disadvantages of solution as a dose form?
- Less stability
- Potential microbial contamination
- Solubility in acceptable solvents
- Taste and smells
- Bulk and weight
- Bulk containers
What are some solubility characterisitcs of solutions?
- Likes dissolves likes
- Inorganis compounds: high water solubiity
- Organic (weak acid or weak base) solubility depends on pH of the solvent
- Salts of organic compounds: high water solubility
- Heating of solvent: may cause precipitation
- Miscibility of liquids, oil and water immiscible
What are the components of a solution?
What is the difference between water for injection and sterile water for injection?
look at book to finish
What does GRAS stand for?
Generally Recognized As Safe
What is a glycogenetic sweetners?
Nutritive sweetners may be converted to energy in the body
What are the classifications of glycogenetic sweetners?
- Sugars: Sucrose, Dextrose (D-Glucose)(L-Glucose is salty), Fructose
- Non-sugars: Sorbitol, Glycerin, Propylene Glycol, Mannitol, Xylitol
What is a non-glycogentic sweetner?
Non-nutritive, non-caloric sweetners, sugar substitutes
What are the classes of non-glycogenetic sweetners?
- Natural: Not hydrolyzed, and not absorbed, methylcellulose, hydroxy ethy cellulose, stevia (heat stable)
- Artifical: Saccharin (sweet n low) unmetabolized, heat stable Cyclamate metabolized carcinogenicity and teratogenizity Aspartame (Equal, Nutrasweet) 3 metabolites, phenylalanine, aspartic acid, methanol, Heat labile Acesulfame Potassium, unmetabolized Sucralose (Splenda) unmetabolized heat stable Neotame similar to aspartame but with less amount of phenylalanine
How many tastes buds are on the tongue?
What is taste?
The combination of flavor, smell, texture, temperature and color
Low molecular weight compounds are:
High molecular weight compounds are:
With organic compound the more OH groups the more:
sweeter it will be
What are the taste that Glaucia wants us to know?
Salty, Sweet, Bitter, Sour/Aicd, Oily, Metalic
What the ingredients to make the colors, yellow, blue, red?
- Yellow: Sulfur and riboflavin
- Blue: Cupric sulfate
- Red: Cyanocobalamine
What is the main synthetic ingredient in coloring agents?
Aniline ( derivative of benzene)
What is the mode of action for preservatives?
Interference with microbial growth, multiplication and metabolism
What is the definition of free water?
Water in a preparation that is not bound to other molecules
What is the role of free water?
Determines the effective concentration of a preservative required for a given liquid (water based) formulation
What are the preservative classification?
- Alcohols and glycerols
- Ethyl Alcohol 95-96%, used 15-17.5%of the free water present in the preparation
- Propylene Glycol (same as ethyl alcohol)
- Glycerin (glycol) Preserve an equal eqilvalent quantity of volume
- Benzoyl Alcohol Bactericidal at 1-2% effectiveness not affected by pH of the solution
What are some organic acid preservatives?
- Benzoic Acid, Na benzoate, K benzoate, [0.1-0.3%], for oral, topical and parenteral dosage forms
- Sorbic Aid, K [0.05-0.2%], for oral and opthalmic
What is a paraben?
- An ester and salt preservative up to 0.1%
- Most effective against fungi
- For all kinds of dosage forms
- Methyl Parabens, Methyl parabens sodium, propyl paraben, butyl paraben
WHat are mercurial derivatives?
- A topical (nasal, ophthalmic) and parenterals preservatives
- Phenylmercui nitrate (PMN) and Phenylmercuric acetate (PMA)
What the purpose of having dry mixtures for solutions?
- Insufficient stability in aqueous medium to meet extended shelf-life
- Lyophilization or spray drying
- Refrigeration after reconstituion for 7-14 days
What is the purpose of a buffer in a solution?
- Maintenance of Ideal pH for drug solubility, stability and product shelf life
- Attention to interactions with anti-microbil preservatives
What is the purpose of a stabilizer in a solution?
- Any additional excipient required to maintain drug in solution, protect drug in its active form
- Keep compatability amoung all components, prevent degradation of drug or product
What is a tincture?
- SOlution with hydroalcoholic or alcoholic vehicle
- Maceration: softening due to soaking steepig
- May contain 15-80% of alcohol, self preserved
Tell me about spray solutions
- Aqueous or oleaginous solutions
- Coarse droplets
- finely divided solids
- Skin, antiseptis, local anesthetics, anitfungals
- Mehcanical devices: Break up solution into small particles
- Facilitate spraying of powder
- Spray bottels
- One way pumps
What is an vaginal solution?
- Douches, feminine hygiene or with anti infective agents for local actions
- Solutions prepated from powders
What is an rectal solution?
- Enemas rectal liquid preparation
- Retention: for local effect or systemic effect
- Evacuation: to clense bowel
What is the definition of a syrup?
Aqueous. sweetened. flavored, viscous solution
What are the types of syrups?
- Non-medicated: Flavored syrups, water soluble drugs, syrup NF 85% sucrose in pH20, ora-sweet: acidic pH and alcohol free
- Medicated: antiemetics, antihistamines, antitussives, antivirals
WHat are the components of syrups?
- Drugs: water solubility
- Solvents: Purified water, alcohol (low concentration)
- Pharmaceutical Ingredients: Seetening agents, Flavoring agents, Coloring agents, Antimicrobial/Antifungal preservatives
What are the techniques in preparing syrups?
- With the aid of heat: sucrose syrups invert sugars, hydrolysis of sucrose to glucose and fructose, some artifical sweeteners are destroyed by heat
- HEat and agitation
WHat is percolation?
per= through, colar= to strain, (preparation of coffee), extracts of crude drugs in comminuted form
What is maceration?
To soak, a tea bag
What are the components of Eixirs?
- Drugs: alcohol-soluble and water-soluble components dissolved separately
- Solvents: water, alcohol, adjunet solvents
- Other pharmaceutical ingredients
What are the pharmaceutical ingredients of an elixir?
- Preservatives: 10-15% is self preserved
What are the concentration of alcohol in ELixirs for 0-6 years old, 6-12 years old, adults
- 0-6 years old: 0.5%
- 6-12 years old: 5%
- Adults: 10-15%
What are the prepatation techniques for an Elixir?
- Simple solution with agitation
- Mixture of alcoholic solution with aqueous solution added to Alocoholic
- Final concetration (talc) if separation of flavoring oils
What are the storage characterisics of an Elixir?
Tight, light resistant container, protect from heat
What is the drug delivery of ophthalmics?
- Topically applied to the eye
- Surface or introcular
What are the main uses for ophthalmic medications?
For infections (bacterial, viral, fungal) allergies, inflammation, elevated intraocular pressure, dry eye
How are ophthalmics applied to the eye?
- Thin ribbon to the lower lid margin
- Insertion of device for contiuouse release of drug
What is the eye capacity?
- Tear fluid in the cul-de-sac 7-8 mcl
- Nonblinking 30mcl vs blinking 10 mcl
- Blinking looses 80% of drop (50 mcl) is lost to tears and the nasolacrimal drainage
How to increase the amount of drug delivered to the eye?
- Increase contact time
- Multiple- drop therapy: time intervals
- Suspension, ointment, Gels
- Oral or parenteral therapy
What are the sterility requirments for ophthalmics?
- Autoclave 121 oC for 15 minutes
- Bacterial 0.2 mcm pore size
what are the ophthalmic that cannot have preservatives?
Surgery, inserts, eye washes used in large quatities, single dose containers
Why do ophthalmic need to be isotonic?
- To make the osmotic pressure similar to the lacrimal fluid 0.9%
- FOr efficacy,safety and comfort ( no burning, tingling, swelling sensation)
- Only when it has the same osmotic pressure as some body fluid
- All the solutes contribute to osmotic pressure
WHat will happen to the eye if an hypertonic solution placed in the eye?
It will draw water out of the eye and cause it to shrink
What will happen to the eye if an hypotonic solution is placed in the eye?
It will draw water into the eye and water enter the cells and may cause them to burst
What is the purpose of a buffer in solution?
- To maintain stability of drug
- Control therapeutic activity
- Reduce discomfort to the patient
- pH of eye is 7.4
What are the USP buffer vehicles for ophthalmic solutions?
- Boric Acid, 1.9% pH~5
- Isotonic phosphate, mixture of monobasic and dibasic salts of phosphat pH~ 5.9-8.0
Why is viscosity important for ophthalmic solutions?
Fast lacrimal drainage; liquids
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