Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.
Pharmaceutical
aids and
necessities
OBJECTIVES
 At the end of the unit, the students should be able
to:
 Identify the different pharmaceutical aids and
nece...
Overview
 Pharmaceutical aids and necessities are
agents important to
 Preparation
 Preservation
 Storage of pharmaceu...
Classification
 Acids and bases
 Buffers
 Antioxidants
 Water
 Glass
 NO therapeutic value
 For making dosage forms
ACIDS, BASES, AND
BUFFERS
 Bronsted-Lowry theory is the acid base theory we
use in the pharmacy because physiologic
funct...
Electrolytes
 Strong acids and bases are strong electrolytes
 Weak acids and bases are weak electrolytes
 Relation
 Th...
OFFICIAL INORGANIC
ACIDS
Boric acid (H3BO3)
 Synonym: boracic acid, hydrogen borate, orthoboric acid
 Occurrences: found in seawaters, certain pl...
Hydrochloric acid (HCl)
 Synonym: chlorhydric acid, spirit of sea salt,
muriatic acid
 Use: a pharmaceutical aid as an a...
Diluted Hydrochloric acid
 Diluted HCl exists in the normal gastric juice
aiding in the conversion of pepsinogen into
pep...
Nitric acid (HNO3)
 Synonym: spirit of nitre, aquafortis, aqua fuerte
 Properties: nitric acid will produce a yellow sta...
Phosphoric acid(H3PO4)
 Synonym: orthophosphoric acid, acido
orthofosforico
 Use: acidifying agent
Diluted phosphoric acid
 Uses: a tonic and stimulant to the gastric
mucous membranes; a synergistic substance
to pepsin a...
Sulfuric acid (H2SO4)
 Synonym: oil of vitriol, vitriolic acid, aceite de vitriole
 Preparation: there are two ways to p...
Acetic acid (CH3COOH)
 Synonym: glacial acetic acid
 Use: irrigation solution with some
bacteriostatic properties
Official Inorganic Bases
1. Strong Ammonia Solution
2. Diluted Ammonia Solution
3. Calcium Hydroxide
4. Potassium Hydroxide
5. Sodium Hydroxide
6. ...
Strong Ammonia Solution (NH4OH)
USP38/NF33
Other Names:
 Ammonium Hydroxide
 Stronger Ammonia Water
Precautions:
 Use c...
Bronsted base
Manufacture of nitric acid and sodium
bicarbonate
Preparation of aromatic spirit
Preparation of ammoniac...
Tollens' reagent is an alkaline solution of ammonia cal
silver nitrate and is used to test for aldehydes
Diluted Ammonia Solution
(NH4OH)
USP38/NF33
 Prepared from strong ammonia solution
 Known as ammonia water or household
...
Calcium Hydroxide Ca(OH)2
USP38/NF33
Other Names:
 Slaked lime
 Calcium hydrate
Preparation:
 Manufactured from lime or...
Medicinally used as fluid electrolyte and topical
astringent
Utilized for its high hydroxide ion concentration in
pharma...
Potassium Hydroxide (KOH)
USP38/NF33
Other Names:
 Caustic potash
 Potassa
Properties:
 Deliquescent
 Very strong base...
Uses:
 As a caustic in veterinary practice
 As a saponifying agent to hydrolyze esters of fatty
acids into their constit...
Sodium Hydroxide (NaOH)
USP38/NF33
Other Names:
 Caustic soda
 Soda lye
Properties:
 It attacks soft glass (containers ...
Uses:
 same as potassium hydroxide but has more
advantage since it is less deliquescent,
milder, and cheaper.
Sodium Carbonate
(Na2CO3.H2O)
USP38/NF33
Other Names:
Monohydrated sodium carbonate
Use:
In pharmaceutical preparations,...
Soda Lime USP38/NF33
Uses:
 A mixture of Ca(OH)2 and NaOH or KOH or
both intended for metabolism tests,
anesthesia, and O...
Potassium Bicarbonate
USP38/NF33
Other Names:
Potassium Hydrogen Carbonate
Potassium Acid Carbonate
Use:
Buffering agen...
Sodium Bicarbonate
USP38/NF33
Other Name:
Sodium Hydrogen Carbonate
Use:
Preferred in preparation of effervescent
mixtur...
BUFFERS
A buffer is a solution of a weak acid and its salt or the salt
of its conjugate base or a weak base and its salt or the
sa...
MECHANISM OF ACTION
 When small amounts of hydrogen ion are
introduced into the medium, they will react with
the conjugat...
If base (OH) is added, it will react with the acid to
neutralize the base, forming acetate ion and water
H2C3O2 + OH → C2H...
EXAMPLES:
ACETIC ACID AND ITS CONJUGATE BASE,
ACETATE ION:
HC2H3O2 (acid) + H20 → H3O + C2H3O2
(conjugate base)
If acid (H...
Consider the following when choosing a buffer:
1. Volatile species should not be used as buffers
2. It should not have any...
TWO INORGANIC BUFFER SYSTEMS
A. PHOSPHATE BUFFER SYSTEM
ADVANTAGE: it contains dihydrogen and
monohydrogen phosphate ions ...
THREE PRIMARY BORATE BUFFER
SYSTEMS:
1. FELDMAN’S BUFFER SYSTEM
- pH of 7.6 – 8.2
- consists of : BORIC ACID, NaCl ( to ma...
STANDARD BUFFER SOLUTIONS
Buffer systems in pharmacy can be roughly categorized into:
1. Standard buffer systems – designe...
- POTASSIUM PHOSPHATE, MONOBASIC 0.2M
- POTASSIUM BIPHTHALATE, 0.2M
- SODIUM HYDROXIDE, 0.2M
- ACETIC ACID, 2N
All the cry...
F
BUFFER pH COMPOSITION
HYDROCHLORIC ACID 1.2 -2 50ml KCl solution with a
specified volume of 0.2 HCl
and water
ACID PHTHA...
Antioxidants
• REDUCING AGENTS
• Pharmaceutical necessity
MECHANISM OF ACTION OF
ANTIOXIDANTS
• Either the antioxidant oxidizes in place of the
active constituent or inversely, the...
 b) The possible TOXICITY of both the reducing
agent and its oxidized product must be assessed
 c) One should consider p...
HYPOPHOSPHOROUS ACID
(HPH2O2)
USES:
• The formation of free iodine is prevented in diluted
hydriodic acid and syrup.
• Its presence in ferrous iodide sy...
Sulfur dioxide (So2
SYNONYM : Sulfurous anhydride
USES:
• It will protect many susceptible compounds from
oxidation by reducing oxidized forms back to their
original compou...
Sodium bisulfite (NaHSO3) or
SODIUM
METABISULFITE(Na2S2O5)
SYNONYMS: SODIUM HYDROGEN SULFITE,
SODIUM ACID SULFITE AND LEUC...
USES:
• It prevents oxidation of the compounds of
phenol or catechol nucleus to quinones.
• Bisulfite may also be found in...
Nitrogen(n2)
Uses:
• As an inert atmosphere, it retards oxidation in
oxidation-sensitive products, and replaces air
in containers for p...
Sodium thiosulfate
Uses:
• Contains sulfur in two different oxidation
states.
• The oxidized sulphur atom is in a +6 state
resisting further ...
Sodium nitrite
Uses:
• Nitrites can act as both a reducing and oxidizing
agent. Reduction of compounds with sodium
nitrite results in for...
Glass
 Red or Pink
Substance added Color imparted
Copper(I) oxide Opaque red, green, blue
Tin (IV) oxide Opaque
Calcium Fluorid...
• Glass is the container material of choice for
most small volume infusions. It is composed
chiefly of silicon dioxide, wi...
• Glass is formed by the silicon oxide
tetrahedron. Though boric oxide will enter
into this structure, most of the other o...
• Selecting the appropriate glass composition is critical
facet of determining the overall specifications for each
parente...
GLASS TYPES
TYPE I – Borosilicate glass
• Composed principally of silicon dioxide and
boric oxide, with low levels of the non-
network...
TYPE II – Soda-lime treated
glass
• The relatively high proportions of sodium
oxide and calcium oxide makes this glass
typ...
• This type is treated under controlled
temperature and humidity conditions with
sulfur dioxide or other dealkalizers to
n...
TYPE III – Soda-lime glass
• These glasses are composed of relatively high
proportions of sodium oxide and calcium oxide,
...
Water
Reagents added to modify the
characteristics/appearance of glass
Special
addition/Composition
Desired Property
Large amoun...
 Water acts as a primary solvent for most
substances due to its properties: small size,
string permanent dipole,high diel...
Natural water
 Alkaline water- usually contain appreciable quantities of
sodoum and magnesium sulfates
 Carbonated water...
Official USP waters
 Most liquid injections are quite dilute; the
component present in the highest proportion
 1.) Purif...
• 3.) Bacteriostatic water for injection
Description : it is prepared from water for injection
that is sterilized and pack...
• 4.) Sterile water for injection
• Description: clear colorless odorless liquid for
parenterals; sterilized; no antimicro...
 6.) Sterile water for inhalation
Description: it is prepared from water for injection, sterilized
and packaged,with no a...
END
Pharmaceutical aids-and-necessities
Pharmaceutical aids-and-necessities
Pharmaceutical aids-and-necessities
Upcoming SlideShare
Loading in …5
×

Pharmaceutical aids-and-necessities

6,823 views

Published on

PharmChem1

Published in: Health & Medicine
  • Have u ever tried external professional writing services like ⇒ HelpWriting.net ⇐ ? I did and I am more than satisfied.
       Reply 
    Are you sure you want to  Yes  No
    Your message goes here
  • Bill Fullilove, disabled with cerebral palsy, and bankrupt from high medical bills, says he was able to turn $150 into $1,000 with the "Demolisher" Betting System: ●●● http://t.cn/A6zP2wH9
       Reply 
    Are you sure you want to  Yes  No
    Your message goes here
  • Dating for everyone is here: ❶❶❶ http://bit.ly/2u6xbL5 ❶❶❶
       Reply 
    Are you sure you want to  Yes  No
    Your message goes here
  • Dating direct: ❶❶❶ http://bit.ly/2u6xbL5 ❶❶❶
       Reply 
    Are you sure you want to  Yes  No
    Your message goes here
  • DOWNLOAD THIS BOOKS INTO AVAILABLE FORMAT (2019 Update) ......................................................................................................................... ......................................................................................................................... Download Full PDF EBOOK here { https://soo.gd/irt2 } ......................................................................................................................... Download Full EPUB Ebook here { https://soo.gd/irt2 } ......................................................................................................................... Download Full doc Ebook here { https://soo.gd/irt2 } ......................................................................................................................... Download PDF EBOOK here { https://soo.gd/irt2 } ......................................................................................................................... Download EPUB Ebook here { https://soo.gd/irt2 } ......................................................................................................................... Download doc Ebook here { https://soo.gd/irt2 } ......................................................................................................................... ......................................................................................................................... ................................................................................................................................... eBook is an electronic version of a traditional print book THIS can be read by using a personal computer or by using an eBook reader. (An eBook reader can be a software application for use on a computer such as Microsoft's free Reader application, or a book-sized computer THIS is used solely as a reading device such as Nuvomedia's Rocket eBook.) Users can purchase an eBook on diskette or CD, but the most popular method of getting an eBook is to purchase a downloadable file of the eBook (or other reading material) from a Web site (such as Barnes and Noble) to be read from the user's computer or reading device. Generally, an eBook can be downloaded in five minutes or less ......................................................................................................................... .............. Browse by Genre Available eBooks .............................................................................................................................. Art, Biography, Business, Chick Lit, Children's, Christian, Classics, Comics, Contemporary, Cookbooks, Manga, Memoir, Music, Mystery, Non Fiction, Paranormal, Philosophy, Poetry, Psychology, Religion, Romance, Science, Science Fiction, Self Help, Suspense, Spirituality, Sports, Thriller, Travel, Young Adult, Crime, Ebooks, Fantasy, Fiction, Graphic Novels, Historical Fiction, History, Horror, Humor And Comedy, ......................................................................................................................... ......................................................................................................................... .....BEST SELLER FOR EBOOK RECOMMEND............................................................. ......................................................................................................................... Blowout: Corrupted Democracy, Rogue State Russia, and the Richest, Most Destructive Industry on Earth,-- The Ride of a Lifetime: Lessons Learned from 15 Years as CEO of the Walt Disney Company,-- Call Sign Chaos: Learning to Lead,-- StrengthsFinder 2.0,-- Stillness Is the Key,-- She Said: Breaking the Sexual Harassment Story THIS Helped Ignite a Movement,-- Atomic Habits: An Easy & Proven Way to Build Good Habits & Break Bad Ones,-- Everything Is Figureoutable,-- What It Takes: Lessons in the Pursuit of Excellence,-- Rich Dad Poor Dad: What the Rich Teach Their Kids About Money THIS the Poor and Middle Class Do Not!,-- The Total Money Makeover: Classic Edition: A Proven Plan for Financial Fitness,-- Shut Up and Listen!: Hard Business Truths THIS Will Help You Succeed, ......................................................................................................................... .........................................................................................................................
       Reply 
    Are you sure you want to  Yes  No
    Your message goes here

Pharmaceutical aids-and-necessities

  1. 1. Pharmaceutical aids and necessities
  2. 2. OBJECTIVES  At the end of the unit, the students should be able to:  Identify the different pharmaceutical aids and necessities  Describe the properties of different pharmaceutical aids  Discuss the importance and application of pharmaceutical aids and necessities to pharmaceutical preparations/
  3. 3. Overview  Pharmaceutical aids and necessities are agents important to  Preparation  Preservation  Storage of pharmaceuticals.
  4. 4. Classification  Acids and bases  Buffers  Antioxidants  Water  Glass  NO therapeutic value  For making dosage forms
  5. 5. ACIDS, BASES, AND BUFFERS  Bronsted-Lowry theory is the acid base theory we use in the pharmacy because physiologic functions and pharmaceuticals are often times dispensed as an aqueous solution.  General chemical expression: HA + B = Aˉ + HB˖  Acid + Base = conjugate base + conjugate acid
  6. 6. Electrolytes  Strong acids and bases are strong electrolytes  Weak acids and bases are weak electrolytes  Relation  The stronger the acid, the weaker its conjugate base, and vice versa.  The stronger the base, the weaker its conjugate acid, and vice versa.
  7. 7. OFFICIAL INORGANIC ACIDS
  8. 8. Boric acid (H3BO3)  Synonym: boracic acid, hydrogen borate, orthoboric acid  Occurrences: found in seawaters, certain plants, in nearly all fruits and in some volcanic stem jets. The nativ boric acid is called sassolite.  Properties: available in three crystalline forms: a) colorless,odorless, pearly scales b) Six-sided triclinic crystals c) White, odorless powder with a soapy feel Uses: antiseptic because it is a weak bacteriostatic agent; in 2% w/c concentration as eyewash and as buffer in opthalmic solutions *the toxicity of boric acid makes it unfit to he taken orally.
  9. 9. Hydrochloric acid (HCl)  Synonym: chlorhydric acid, spirit of sea salt, muriatic acid  Use: a pharmaceutical aid as an acidifying agent
  10. 10. Diluted Hydrochloric acid  Diluted HCl exists in the normal gastric juice aiding in the conversion of pepsinogen into pepsin and of proteins into peptones and serving as a gastric antiseptic. It is also used in the management id gastric achlorhydria, the absence if HCl in the stomach; and hypochlorhydria, the deficiency of HCl production of the stomach.
  11. 11. Nitric acid (HNO3)  Synonym: spirit of nitre, aquafortis, aqua fuerte  Properties: nitric acid will produce a yellow stain on animal tissue due to the nitration of the aromatic amino acid, phenylamine, tyrosine and tryptophan found in the proteins of skin. This reaction is known as xanthoproteic test. It oxidizes common metals except gold and platinum to produce the nitrate salt of the metal.  Uses: the manufacture of sulfuric acid, coal tar dyes and explosives; a nitrating agent in pyroxylin USP XVIII; a source of nitrate ion in the preparation of milk of bismuth; externally, the elimination of chancres and warts.
  12. 12. Phosphoric acid(H3PO4)  Synonym: orthophosphoric acid, acido orthofosforico  Use: acidifying agent
  13. 13. Diluted phosphoric acid  Uses: a tonic and stimulant to the gastric mucous membranes; a synergistic substance to pepsin and acids to the formulation of peptones
  14. 14. Sulfuric acid (H2SO4)  Synonym: oil of vitriol, vitriolic acid, aceite de vitriole  Preparation: there are two ways to prepare sulfuric acid: contact pr catalytic process and the Lead chamber process. Blth have the same principle, that is, the oxidation of the sulfur dioxide to sulfur trioxide by adding enough water to form sulfuric acid. In the catalytic process, vanadium and platinized silica gels are catalyst.  Use: dehydrating agent in the preparation of pyroxylin USP XX
  15. 15. Acetic acid (CH3COOH)  Synonym: glacial acetic acid  Use: irrigation solution with some bacteriostatic properties
  16. 16. Official Inorganic Bases
  17. 17. 1. Strong Ammonia Solution 2. Diluted Ammonia Solution 3. Calcium Hydroxide 4. Potassium Hydroxide 5. Sodium Hydroxide 6. Sodium Carbonate 7. Soda Lime 8. Potassium Bicarbonate 9. Sodium Bicarbonate
  18. 18. Strong Ammonia Solution (NH4OH) USP38/NF33 Other Names:  Ammonium Hydroxide  Stronger Ammonia Water Precautions:  Use care in handling (caustic nature and irritating properties of its vapor)  Cool the container well before opening  Cover the closure with cloth while opening  Do not taste or inhale the vapors
  19. 19. Bronsted base Manufacture of nitric acid and sodium bicarbonate Preparation of aromatic spirit Preparation of ammoniacal silver nitrate solution
  20. 20. Tollens' reagent is an alkaline solution of ammonia cal silver nitrate and is used to test for aldehydes
  21. 21. Diluted Ammonia Solution (NH4OH) USP38/NF33  Prepared from strong ammonia solution  Known as ammonia water or household ammonia  Employed as circulatory stimulant through inhalation of vapors USES  When used externally, it is counter-irritant
  22. 22. Calcium Hydroxide Ca(OH)2 USP38/NF33 Other Names:  Slaked lime  Calcium hydrate Preparation:  Manufactured from lime or Calcium Oxide by slaking process.
  23. 23. Medicinally used as fluid electrolyte and topical astringent Utilized for its high hydroxide ion concentration in pharmaceutical preparations. Its alkalinity reacts with free fatty acids in various oils to form calcium soaps which have emulsifying properties. Due to its ability to absorb CO2 from expired air, it is combined with NaOH or KOH in a mixture known as soda lime
  24. 24. Potassium Hydroxide (KOH) USP38/NF33 Other Names:  Caustic potash  Potassa Properties:  Deliquescent  Very strong base with caustic/ corrosive effect on tissues (handle carefully)
  25. 25. Uses:  As a caustic in veterinary practice  As a saponifying agent to hydrolyze esters of fatty acids into their constituent alcohols and potassium salt
  26. 26. Sodium Hydroxide (NaOH) USP38/NF33 Other Names:  Caustic soda  Soda lye Properties:  It attacks soft glass (containers should be made of hard glass with rubber stoppers  Glass-stoppered bottles can be used if a liitle petroleum or paraffin is spread around the stopper  Not borosilicate, a soft glass has high coefficients of thermal expansion; thus it does not require a high temperature to make them soft.
  27. 27. Uses:  same as potassium hydroxide but has more advantage since it is less deliquescent, milder, and cheaper.
  28. 28. Sodium Carbonate (Na2CO3.H2O) USP38/NF33 Other Names: Monohydrated sodium carbonate Use: In pharmaceutical preparations, its basicity forms sodium salts of acidic drugs
  29. 29. Soda Lime USP38/NF33 Uses:  A mixture of Ca(OH)2 and NaOH or KOH or both intended for metabolism tests, anesthesia, and O2 therapy.
  30. 30. Potassium Bicarbonate USP38/NF33 Other Names: Potassium Hydrogen Carbonate Potassium Acid Carbonate Use: Buffering agent for pharmaceutical preparations
  31. 31. Sodium Bicarbonate USP38/NF33 Other Name: Sodium Hydrogen Carbonate Use: Preferred in preparation of effervescent mixtures containing sodium bicarbonate and organic acids such as tartaric or citric. These additives react to liberate CO2 that acts as a disintegrator producing effervescence when in water.
  32. 32. BUFFERS
  33. 33. A buffer is a solution of a weak acid and its salt or the salt of its conjugate base or a weak base and its salt or the salt of its conjugate acid that resists drastic changes in pH when small amounts of acid or base are added to it. Buffers control the pH of pharmaceutical products within certain specified limits for these reasons: A. Chemical Stability B. Solubility of the drug C. Patient’s comfort Some factors which can produce alterations in pH include: A. Alkali in certain inexpensive containers B. Gases present in air such as CO2 and NH3
  34. 34. MECHANISM OF ACTION  When small amounts of hydrogen ion are introduced into the medium, they will react with the conjugate base and basic members of the buffer to form a weak acid.  Similarly,when small amounts of hydroxide ion are introduced into the medium, they will react with the weak acid or acidic member of the buffer pair and form water and the conjugate base.  Hence,each component of the buffer pair will react with either acid or base to form the other component
  35. 35. If base (OH) is added, it will react with the acid to neutralize the base, forming acetate ion and water H2C3O2 + OH → C2H3O2 + H2O The selected buffer should not: A. Participate in oxidation-reduction reaction B. Alter the solubility of other components C. Form complexes with active ingredients
  36. 36. EXAMPLES: ACETIC ACID AND ITS CONJUGATE BASE, ACETATE ION: HC2H3O2 (acid) + H20 → H3O + C2H3O2 (conjugate base) If acid (H3O) is added, it will react with the conjugate base to neutralize the acid, forming acetic acid and water C2H3O2 + H3O → HC2H3O2 + H2O
  37. 37. Consider the following when choosing a buffer: 1. Volatile species should not be used as buffers 2. It should not have any influence on the pharmacological activity of the API 3. The use of the pharmaceutical should be considered in choosing a buffer for a product. If it is to be ingested, buffers containing borates should not be used as they are toxic systemically.
  38. 38. TWO INORGANIC BUFFER SYSTEMS A. PHOSPHATE BUFFER SYSTEM ADVANTAGE: it contains dihydrogen and monohydrogen phosphate ions which are found normally in the body DISADVANTAGE: The insolubility of the phosphate salts of such metals such as Ag, Zn, and Al support microbial growth B. BORATE BUFFER SYSTEM It contains metals that would precipitate in the presence of phosphate. They are toxic and it is suitable in external preparations, ophthalmic, and nasal solutions but is contraindicated in parenteral solutions.
  39. 39. THREE PRIMARY BORATE BUFFER SYSTEMS: 1. FELDMAN’S BUFFER SYSTEM - pH of 7.6 – 8.2 - consists of : BORIC ACID, NaCl ( to make it isotonic), and Sodium Borate 2. ATKINS AND PANTIN BUFFER SYSTEM - pH of 7.6 – 11 - consists of: Sodium carbonate, Boric acid, and NaCl 3. GIFFORD BUFFER SYSTEM: - pH of 6 – 7.6 - similar to Feldman’s Buffer System but NaCl is replaced by KCl to make it hypotonic
  40. 40. STANDARD BUFFER SOLUTIONS Buffer systems in pharmacy can be roughly categorized into: 1. Standard buffer systems – designed to provide a solution having a specific pH for analytical purposes. 2. Actual pharmaceutical buffers – designed to maintain pH limits in drug preparations Standard buffer solutions having pH ranges between 1.2 and 10.00 can be prepared by appropriate combinations of: - BORIC ACID AND POTASSIUM CHLORIDE, 0.2M - HYDROCHLORIC ACID, 0.2M - POTASSIUM CHLORIDE, 0.2M
  41. 41. - POTASSIUM PHOSPHATE, MONOBASIC 0.2M - POTASSIUM BIPHTHALATE, 0.2M - SODIUM HYDROXIDE, 0.2M - ACETIC ACID, 2N All the crystalline reagents except boric acid should be dried at 110 – 120 degrees Celsius for an hour before use. The water should also be CO2-free. The solution should be stored in Type 1 glass bottles and the solutions used within 3 months. The solutions, prepared and standardized, will later be combined in specific quantities to make the following standard buffer solutions to achieve a certain pH.
  42. 42. F BUFFER pH COMPOSITION HYDROCHLORIC ACID 1.2 -2 50ml KCl solution with a specified volume of 0.2 HCl and water ACID PHTHALATE BUFFER 2.2-4.O 50 ml of potassium biphthalate solution with a specified volume of 0.2 HCl and water NEUTRALIZED PHTHALATE BUFFER 4.5-5.8 50 ml of potassium biphthalate with a specified volume of NaOH and water PHOSPHATE BUFFER 5.8-8.0 50 ml of monobasic potassium phosphate with NaOH and water ALKALINE BORATE BUFFER 8.0-10.0 50ml of boric acid and KCl with NaOH and water ACETATE BUFFER 4.1-5.5 Specified amount of sodium acetate with acetic acid and water
  43. 43. Antioxidants
  44. 44. • REDUCING AGENTS • Pharmaceutical necessity
  45. 45. MECHANISM OF ACTION OF ANTIOXIDANTS • Either the antioxidant oxidizes in place of the active constituent or inversely, the antioxidant reduces the already oxidized active constituent back to its normal oxidation state. • In selecting a suitable antioxidant, the following factors should be considered:  a) An antioxidant in a pharmaceutical preparation should be PHYSIOLOGICALLY INERT
  46. 46.  b) The possible TOXICITY of both the reducing agent and its oxidized product must be assessed  c) One should consider possible SOLUBILITY problems between the reducing agent and the drug  d) VERY STRONG reducing agent will form explosive mixtures when combined in dry form or in concentrated solution with strong oxidizing agents
  47. 47. HYPOPHOSPHOROUS ACID (HPH2O2)
  48. 48. USES: • The formation of free iodine is prevented in diluted hydriodic acid and syrup. • Its presence in ferrous iodide syrup ensures the non-formation of both ferric ions and molecular iodine. • Salts of hypophosphorus acid are antioxidants. • Sodium hypophosphite is a preservative in certain foods. • Ammonium hypophosphite is likewise a preservative in many preparations.
  49. 49. Sulfur dioxide (So2 SYNONYM : Sulfurous anhydride
  50. 50. USES: • It will protect many susceptible compounds from oxidation by reducing oxidized forms back to their original compounds or by reacting with oxygen before the susceptible compounds do. • It is usually in injectable preparations in ampules or vials. • It is used in industry to bleach wood pulp, to fumigate grains and to arrest fermentation
  51. 51. Sodium bisulfite (NaHSO3) or SODIUM METABISULFITE(Na2S2O5) SYNONYMS: SODIUM HYDROGEN SULFITE, SODIUM ACID SULFITE AND LEUCOGEN
  52. 52. USES: • It prevents oxidation of the compounds of phenol or catechol nucleus to quinones. • Bisulfite may also be found in ascorbic acid injections as a reducing agent. • It prepares water-soluble derivatives of normally insoluble drugs. • Metabisulfite is an ascorbic acid injections as reducing agent.
  53. 53. Nitrogen(n2)
  54. 54. Uses: • As an inert atmosphere, it retards oxidation in oxidation-sensitive products, and replaces air in containers for parenterals and solutions for topical applications.
  55. 55. Sodium thiosulfate
  56. 56. Uses: • Contains sulfur in two different oxidation states. • The oxidized sulphur atom is in a +6 state resisting further oxidation, whereas the remaining sulphur atom is in a zero oxidation state. This oxidation polarity allows the compound to act as a reducing agent. Also, sodium thiosulfate acts as an antidote for cyanide poisoning.
  57. 57. Sodium nitrite
  58. 58. Uses: • Nitrites can act as both a reducing and oxidizing agent. Reduction of compounds with sodium nitrite results in formation of nitrates. • It is an antidote for cyanide poisoning. • Nitrites in brine solutions are curing ingredients of meats and fish for they are excellent color developer, enhance flavor production, and prevent microbial growth. However, nitrite ions remain in cured meats and react with organic amines to form potentially carcinogenic N- nitrosamines.
  59. 59. Glass
  60. 60.  Red or Pink Substance added Color imparted Copper(I) oxide Opaque red, green, blue Tin (IV) oxide Opaque Calcium Fluoride Milky white Manganese (IV) oxide Violet Cobalt (II) oxide Blue Finely divided gold Red, Purple, Blue Uranium compounds Yellow, Green Iron (II) compounds Green Iron (III) compounds) Yellow Chromium Green Cadmium sulfide Yellow Selenium Red or Pink
  61. 61. • Glass is the container material of choice for most small volume infusions. It is composed chiefly of silicon dioxide, with varying amounts of other oxides like sodium, potassium, calcium, magnesium, aluminum, boron and iron. • The following are added to imaprt color to the glass
  62. 62. • Glass is formed by the silicon oxide tetrahedron. Though boric oxide will enter into this structure, most of the other oxides do not. • Glass types are determined from the result of two USP tests: the powdered glass test and water attack test. The latter is used for type II glass.
  63. 63. • Selecting the appropriate glass composition is critical facet of determining the overall specifications for each parenteral formulation. • Source or cause of leachables/extractables, adsorption formulation components, especially proteins, and cracks or scratches. • Leachability- is a property in which ions from the glass container will leach out and interact with the product, thereby reducing the stability of the product.  Delamination or glass particulate formation- is caused by the chemical attack on the glass matrix by the formulation solution, resulting in the weakening of the glass and eventual dislodgement of flakes from the glas surface.
  64. 64. GLASS TYPES
  65. 65. TYPE I – Borosilicate glass • Composed principally of silicon dioxide and boric oxide, with low levels of the non- network-forming oxides, it is a chemically resistant glass (low leachability) with low thermal coefficient of expansion. • This type of container is suitable for all products although sulfur dioxide treatment sometimes is added to further increase its resistance.
  66. 66. TYPE II – Soda-lime treated glass • The relatively high proportions of sodium oxide and calcium oxide makes this glass type chemically less resistant. • Type II melts at lower temperature, rendering it easier to mold into various shapes; and has a higher thermal coefficient of expansion than Type I. • It has a lower concentration of the migratory oxides than Type III.
  67. 67. • This type is treated under controlled temperature and humidity conditions with sulfur dioxide or other dealkalizers to neutralize the interior surface of the container. • Type II glasses may be suitable for a solution that is buffered, has a pH below 7, or is not reactive with glass.
  68. 68. TYPE III – Soda-lime glass • These glasses are composed of relatively high proportions of sodium oxide and calcium oxide, a combination that renders the glass chemically less resistant. • They melt at lower temperature, are easier to mold into various shapes, and have a higher thermal coefficient of expansion than Type I. • Type III glasses are suitable principally for anhydrous liquids or dry substances. • 4. NP – Soda- lime glass not suitable for containers for parenterals
  69. 69. Water
  70. 70. Reagents added to modify the characteristics/appearance of glass Special addition/Composition Desired Property Large amounts of PbO with SiO2 and Na2CO3 Brilliance, Clarity, Suitability for optical structures; crystals or flint glass SiO2, B2O3, and small amounts of Al2O3 Small coefficient if thermal expansion; borosillicate glass One part SiO2 and four parts PbO Ability to stop (absorb) large amounts of X-rays and gamma rays: lead glass Large concentrations of As2O3 Transparency to infrared radiation
  71. 71.  Water acts as a primary solvent for most substances due to its properties: small size, string permanent dipole,high dielectric constant and availability for protons for hydrogen bonding.  Pure water is a tasteless, odorless, clear liquid which is colorless in small quantities and greenish blue in deep layers.  Due to solvent powers and physiological inertness, water is an extremely important pharmaceutical agent.
  72. 72. Natural water  Alkaline water- usually contain appreciable quantities of sodoum and magnesium sulfates  Carbonated waters- charged with carbon dioxide under pressure while in earth.  Chalybdate waters- have iron in solution or in suspension and are characterized by a ferrigenous taste.  Lithia waters- occur in the form of carbonate or chloride  Saline waters- also known as "purgative waters" , hold relatively large amount of magnesium and sodium sulfates with sodium chloride.  Sulfur waters- have hydrogen sulfide  siliceous waters- include very small amounts of soluble alkali silicates.
  73. 73. Official USP waters  Most liquid injections are quite dilute; the component present in the highest proportion  1.) Purified water  2.) Water for injection Description: clear colorless odorless liquid purified by distillation or reverse osmosis and contains no added substances. Use: pharmaceutic aid as a vehicle or solvent
  74. 74. • 3.) Bacteriostatic water for injection Description : it is prepared from water for injection that is sterilized and packaged in prefilled syringes or in vials containing not more than 30 mL. It also has one or more suitable antimicrobial agents. Use: sterile vehicle for parenteral preparations NOTE: label should state: "NOT FOR USE IN NEONATES" as there were problems encountered with neonates and the toxicity of the bacteriostat, benzyl alcohol.
  75. 75. • 4.) Sterile water for injection • Description: clear colorless odorless liquid for parenterals; sterilized; no antimicrobial agent or other added substances • 5.)Sterile water for irrigation Description: clear, Colorless, odorless liquid; water for injection that has been sterilized; no antimicrobial agent or other substances Use: an irrigating solution NOTE: label must say "For irrigation only and not for injection"
  76. 76.  6.) Sterile water for inhalation Description: it is prepared from water for injection, sterilized and packaged,with no added antimicrobial agents. Heavy water is isotopes of hydrogen (deuterium and tritium)
  77. 77. END

×