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TYPE OF WATER USP DESCRIPTION ADMINISTRATION
Purified Water, USP - Water obtained via distillation, ion exchange, or other suitable treatment.
- It cannot contain more than 10 parts per million (ppm) of total solid.
- pH level must be between 7 and 7.
- Used in prescriptions and finished manufactured products except parenteral
and ophthalmic products.
Water for injection, USP - Obtained via distillation or reverse osmosis
- Conforms to the standards of purified water but also is free of pyrogen.
- Used as a solvent for the preparation of parenteral solutions.
Sterile Water for injection, USP - Sterilized and packaged in single-dose containers type I and II glass.
- These containers do not exceed a capacity of 1L.
- The limitations for total solids depend on the size of the container.
Bacteriostatic Water for injection, USP - Contains one or more suitable antimicrobial agents.
- Packaged in single-dose or multiple dose container of type I and II glass.
- These containers do not exceed the capacity of 30 mL.
Sterile Water for Inhalation, USP - Obtained via distillation or reverse osmosis and rendered sterile.
- No microbial agents are present except when used in humidifiers or similar devices.
- Should not be used for parenteral administration or for other sterile dosage
forms.
Sterile Water for irrigation, USP - Water for injection that is sterilized and suitably packaged.
- Contains no antimicrobial agents or for other sterile dosage forms.
Sterile purified water, USP - Purified water that is sterilized and suitably packaged.
- Contains no antimicrobial agent
- Not intended for use in parenteral
Descriptive Term Parts of the solvent required per part of solute
Very Soluble Less than 1
Freely Soluble 1 to 10
Soluble 10 to 30
Sparingly Soluble 30 to 100
Slightly Soluble 100 to 1000
Very Slightly Soluble 1000 to 10000
Practically Insoluble Greater than 10000
Comminution or Milling:
- The mechanical process of reducing the particle size of solids before mixing with other components, further processing or incorporation into the final product.
Micromeritics: is the study of particles.
Advantages:
1. Increases the surface area which may increase the dissolution rate and bioavailability. (e.g. griseofulvin)
2. Increases the extraction or leaching from animal glands. (e.g. liver, pancreas) and from crude vegetables extracts.
3. Facilitates drying of wet masses by increasing the surface area and reducing the distance that moisture must travel to reach the other surface.
4. Improves mixing or blending of several solid ingredients if they are reduced to approximately the same size; also minimizes segregation and provides greater dose uniformity.
5. Permits uniform distribution.
6. Improves the function of lubricants used to coat the surface of the granulation or powder.
Disadvantages:
1. Can change the polymorphic form of the active ingredient, reducing it less active.
2. Can degrade the drug as a result of heat and oxidation or adsorption of unwanted moisture because of increased surface area.
TYPE OF POWDER SIEVE SIZE ALL PARTICLES PASS THROUGH SIEVE SIZE PERCENTAGE OF PARTICLES PASS THROUGH
Very Coarse (#8) #20 sieve 20% through a #60 sieve
Coarse (#20) #20 sieve 40% through a #60 sieve
Moderately Coarse (#40) #40 sieve 40% through a #80 sieve
Fine (#60) #60 sieve 40% through a #100 sieve
Very Fine (#80) #80 sieve No limit
COMMUNITION TECHNIQUES
TRITURATION PULVERIZATION BY INTERVENTION LEVIGATION MILLING
- Grinding a drug in a mortar and pestle.
- Aid of an additional material that can be
removed easily after the pulverization has been
completed.
- Triturating a drug with a small amount of
non-solvent liquid (levigating agent)
- Large scale comminution.
TYPES OF POWDERS
BULK POWDERS DIVIDED POWDERS
- Used in bulk and measured by the spoonful to use as is or to make a solution.
Examples: Oral powders, dentifrices, douche powders, dusting powders, insufflations, trituration (10% API)
- Chartula or chartulae
- Dispensed in the form of individual doses.
GLASS WEDGEWOOD PORCELAIN
- Is designed primarily for use in preparing solutions and
suspensions of chemical materials in a liquid. Also are suitable for
preparing for ointments.
- Are suited for the communition of crystalline solids.
- It is relatively porous and will stain quite easily.
- Are very similar to Wedgewood.
- Except that the exterior surface of the former is usually glazed and
thus less porous.
TYPES OF PAPER DESCRIPTION
Vegetable Parchment Is a thin, semi opaque, moisture-resistant paper.
White Bond Paper Is an opaque paper that has no moisture-resistant properties
Glassine Is a glazed, transparent, moisture- resistant paper
Waxed Paper Is transparent waterproof paper
CAPSULES:
HARD GELATIN CAPSULES SOFT GELATIN CAPSULES
- Dry filled or two-piece capsules (cap and body)
- Made of gelatin, suar, water, colorant and opacifying agent (TiO2) + SO2
- Prepared from gelatin shells Glycerin or polyhydric alcohol (e.g. sorbitol) which is added to these shells to
make them elastic or plastic-like.
CAPSULE DESIGN DESCRIPTION
Pulvules Tapering body, rounded cap end
Spansule Ends of the body and cap tapered
Snap-fir/ Coni-snap Two halves of the capsule shell to be positively joined through locking-grooves in the shell walls
Kapseals Distinctive looking capsules with colored bands of gelatin.
Soft Gelatin Capsules:
- Are oblong, elliptical or spherical.
- Used to contain liquids, suspensions, pastes, dry powders or pellets.
Commercially prepared in soft capsules:
1. Demeclocycline Hydrochloride (Declomycin, Lederle)
2. Chloral Hydrate
3. Digoxin (Lanoxicaps, GlaxoSmithKline)
4. Vitamin A and Vitamin E
*Usually prepared by the plate process or by the rotary or reciprocating die process.

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Reviewer-unit-4.pdf

  • 1. TYPE OF WATER USP DESCRIPTION ADMINISTRATION Purified Water, USP - Water obtained via distillation, ion exchange, or other suitable treatment. - It cannot contain more than 10 parts per million (ppm) of total solid. - pH level must be between 7 and 7. - Used in prescriptions and finished manufactured products except parenteral and ophthalmic products. Water for injection, USP - Obtained via distillation or reverse osmosis - Conforms to the standards of purified water but also is free of pyrogen. - Used as a solvent for the preparation of parenteral solutions. Sterile Water for injection, USP - Sterilized and packaged in single-dose containers type I and II glass. - These containers do not exceed a capacity of 1L. - The limitations for total solids depend on the size of the container. Bacteriostatic Water for injection, USP - Contains one or more suitable antimicrobial agents. - Packaged in single-dose or multiple dose container of type I and II glass. - These containers do not exceed the capacity of 30 mL. Sterile Water for Inhalation, USP - Obtained via distillation or reverse osmosis and rendered sterile. - No microbial agents are present except when used in humidifiers or similar devices. - Should not be used for parenteral administration or for other sterile dosage forms. Sterile Water for irrigation, USP - Water for injection that is sterilized and suitably packaged. - Contains no antimicrobial agents or for other sterile dosage forms. Sterile purified water, USP - Purified water that is sterilized and suitably packaged. - Contains no antimicrobial agent - Not intended for use in parenteral Descriptive Term Parts of the solvent required per part of solute Very Soluble Less than 1 Freely Soluble 1 to 10 Soluble 10 to 30 Sparingly Soluble 30 to 100 Slightly Soluble 100 to 1000 Very Slightly Soluble 1000 to 10000 Practically Insoluble Greater than 10000
  • 2. Comminution or Milling: - The mechanical process of reducing the particle size of solids before mixing with other components, further processing or incorporation into the final product. Micromeritics: is the study of particles. Advantages: 1. Increases the surface area which may increase the dissolution rate and bioavailability. (e.g. griseofulvin) 2. Increases the extraction or leaching from animal glands. (e.g. liver, pancreas) and from crude vegetables extracts. 3. Facilitates drying of wet masses by increasing the surface area and reducing the distance that moisture must travel to reach the other surface. 4. Improves mixing or blending of several solid ingredients if they are reduced to approximately the same size; also minimizes segregation and provides greater dose uniformity. 5. Permits uniform distribution. 6. Improves the function of lubricants used to coat the surface of the granulation or powder. Disadvantages: 1. Can change the polymorphic form of the active ingredient, reducing it less active. 2. Can degrade the drug as a result of heat and oxidation or adsorption of unwanted moisture because of increased surface area. TYPE OF POWDER SIEVE SIZE ALL PARTICLES PASS THROUGH SIEVE SIZE PERCENTAGE OF PARTICLES PASS THROUGH Very Coarse (#8) #20 sieve 20% through a #60 sieve Coarse (#20) #20 sieve 40% through a #60 sieve Moderately Coarse (#40) #40 sieve 40% through a #80 sieve Fine (#60) #60 sieve 40% through a #100 sieve Very Fine (#80) #80 sieve No limit COMMUNITION TECHNIQUES TRITURATION PULVERIZATION BY INTERVENTION LEVIGATION MILLING - Grinding a drug in a mortar and pestle. - Aid of an additional material that can be removed easily after the pulverization has been completed. - Triturating a drug with a small amount of non-solvent liquid (levigating agent) - Large scale comminution. TYPES OF POWDERS BULK POWDERS DIVIDED POWDERS - Used in bulk and measured by the spoonful to use as is or to make a solution. Examples: Oral powders, dentifrices, douche powders, dusting powders, insufflations, trituration (10% API) - Chartula or chartulae - Dispensed in the form of individual doses. GLASS WEDGEWOOD PORCELAIN - Is designed primarily for use in preparing solutions and suspensions of chemical materials in a liquid. Also are suitable for preparing for ointments. - Are suited for the communition of crystalline solids. - It is relatively porous and will stain quite easily. - Are very similar to Wedgewood. - Except that the exterior surface of the former is usually glazed and thus less porous.
  • 3. TYPES OF PAPER DESCRIPTION Vegetable Parchment Is a thin, semi opaque, moisture-resistant paper. White Bond Paper Is an opaque paper that has no moisture-resistant properties Glassine Is a glazed, transparent, moisture- resistant paper Waxed Paper Is transparent waterproof paper CAPSULES: HARD GELATIN CAPSULES SOFT GELATIN CAPSULES - Dry filled or two-piece capsules (cap and body) - Made of gelatin, suar, water, colorant and opacifying agent (TiO2) + SO2 - Prepared from gelatin shells Glycerin or polyhydric alcohol (e.g. sorbitol) which is added to these shells to make them elastic or plastic-like. CAPSULE DESIGN DESCRIPTION Pulvules Tapering body, rounded cap end Spansule Ends of the body and cap tapered Snap-fir/ Coni-snap Two halves of the capsule shell to be positively joined through locking-grooves in the shell walls Kapseals Distinctive looking capsules with colored bands of gelatin. Soft Gelatin Capsules: - Are oblong, elliptical or spherical. - Used to contain liquids, suspensions, pastes, dry powders or pellets. Commercially prepared in soft capsules: 1. Demeclocycline Hydrochloride (Declomycin, Lederle) 2. Chloral Hydrate 3. Digoxin (Lanoxicaps, GlaxoSmithKline) 4. Vitamin A and Vitamin E *Usually prepared by the plate process or by the rotary or reciprocating die process.