Injectable Solutions and Stability
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Questions and Answers

What are solid consistency preparations that contain a dosage unit of one or more active substances called?

Tablets

What ingredient is essential to bond particles that cannot be compressed alone?

Binder

What is used to increase tablet size when the active ingredient is insufficient?

Diluent

When should lubricants be added during tablet preparation?

<p>At the beginning of dry mixing</p> Signup and view all the answers

What issue can arise from the use of excessive lubricant in tablet formulation?

<p>Tablet friability</p> Signup and view all the answers

What is the primary role of disintegrants in tablet formulations?

<p>Accelerate disintegration</p> Signup and view all the answers

What is the purpose of granulation in tablet manufacturing?

<p>To increase powder density</p> Signup and view all the answers

What shape is typically associated with a punch used in tablet compression machines?

<p>Nail-shaped</p> Signup and view all the answers

What is the position of the hopper and hoof during the ejection process in the alternative machine?

<p>They are moving horizontally to feed the matrix and push the tablet out.</p> Signup and view all the answers

What are parenteral preparations intended for?

<p>They are sterile preparations intended to be injected or implanted in the human or animal body.</p> Signup and view all the answers

How can the average weight of the tablets be increased in the alternate machine?

<p>By lowering the lower punch.</p> Signup and view all the answers

What action affects the hardness of the tablets in an alternate machine?

<p>Lowering the upper punch.</p> Signup and view all the answers

How can precipitates be removed from injectable solutions?

<p>By clarifying filtration using the 0.22 μm millipore filter.</p> Signup and view all the answers

What is considered the fixed part in a rotary machine?

<p>The hopper and hoof.</p> Signup and view all the answers

What is the typical pH range of body fluids?

<p>The pH range of body fluids is 7.35 to 7.45.</p> Signup and view all the answers

What is the control method for uniformity of weight in tablets?

<p>At least 18 tablets should fall within the range [AW±e].</p> Signup and view all the answers

What adjustment is made if an active pharmaceutical ingredient is only stable at pH 3?

<p>Acidify with hydrochloric acid.</p> Signup and view all the answers

What causes longer pain in buffered injectable solutions?

<p>The competition of drug buffer and tampons of the body.</p> Signup and view all the answers

What should be done to resolve a pH problem in eye drops if its active principle is stable outside neutrality?

<p>Adjust the pH with acids or bases.</p> Signup and view all the answers

What is the purpose of NaCl in eye drops?

<p>It adjusts the osmotic pressure.</p> Signup and view all the answers

What is the concentration of NaCl in an isotonic solution?

<p>The concentration of NaCl is 0.9%.</p> Signup and view all the answers

What defines a semi-solid preparation intended for skin application?

<p>They exert a local action or facilitate percutaneous penetration of medicinal principles.</p> Signup and view all the answers

What is the boiling point of syrup?

<p>The boiling point of syrup is 105°C.</p> Signup and view all the answers

Why is more sugar used in preparing cold simple syrup than in hot preparation?

<p>Due to the evaporation of steam during heating.</p> Signup and view all the answers

What is the mass of cocoa butter needed to prepare 10 suppositories of 0.1 g phenobarbital with a displacement factor of 0.62?

<p>29.38 g</p> Signup and view all the answers

What is the definition of rectal capsules?

<p>Soft capsules of slightly elongated shape containing an active principle and a pasty or liquid excipient.</p> Signup and view all the answers

What form of medicine is intended to be introduced into the woman's sexual cavity?

<p>Ovule</p> Signup and view all the answers

What method involves melting the excipient and incorporating active ingredients into molds?

<p>Method of preparing ovules</p> Signup and view all the answers

How are ovules typically packaged?

<p>PVC / Alu Blisters</p> Signup and view all the answers

What is the standard disintegration time for ovules?

<p>60 minutes</p> Signup and view all the answers

What do you call liquids intended to wash the throat?

<p>Gargarisms</p> Signup and view all the answers

What size of particles can penetrate the nasal cavity?

<blockquote> <p>30 μm</p> </blockquote> Signup and view all the answers

What are semi-solid preparations intended for multi-phase skin application called?

<p>Cream</p> Signup and view all the answers

What types of emulsifying agents are sodium soaps, sulfated fatty alcohols, and polysorbates classified as?

<p>Emulsifying agents type L/H</p> Signup and view all the answers

What are semi-solid preparations formed from liquids gelled by gelling agents called?

<p>Gels</p> Signup and view all the answers

What is the main principle of preparing hydrophobic gels?

<p>Dissolve or disperse one or more p.a. in hydrophobic gelling agents.</p> Signup and view all the answers

What impact does the pH of the PSSAC have on medication penetration through the skin?

<p>It influences the degree of ionization of ionizable active ingredients.</p> Signup and view all the answers

Why is kneading important during the manufacturing of PSSACs?

<p>To avoid the separation of excipients.</p> Signup and view all the answers

How is homogeneity in PSSAC checked?

<p>By thin-layer spreading on a flat surface using a spatula.</p> Signup and view all the answers

What apparatus is used to measure the hardness of ointments?

<p>Penetrometer</p> Signup and view all the answers

Study Notes

Injectable Solutions

  • Sterile preparations for injection or implantation in humans or animals
  • Parenteral use is the classification
  • Filtration using a 0.22 µm millipore filter for removing precipitates, crystals, and fibers
  • Body fluids have a pH range of 7.35 to 7.45

Injectable Preparation pH

  • Injectable preparations need a neutral pH, ideally matching body fluid pH
  • pH tolerance by the body is a critical condition to maintain
  • If API (active pharmaceutical ingredient) is stable only at pH 3, acidify with hydrochloric acid
  • If API is stable at pH 5–6, buffer with a pH buffer of about 5–6

Injectable Solution Instability

  • If the solution of the active ingredient is unstable at any pH, present the active substance in sterile powder for dissolution at the time of use

Isotonic Solutions

  • Isotonic solutions do not cause swelling or distortion of erythrocytes
  • Isotonic NaCl concentration is 0.9%
  • Isotonic glucose concentration is 5%

Hemolysis

  • Hemolysis (rupture of red blood cells) occurs above 0.48% NaCl concentration

Syrups

  • Aqueous liquid preparations high in sugar
  • Provide consistency and preservation
  • Cold simple syrup: 1800g sugar per 1000g water
  • Hot single syrup (closed container): 1800g sugar per 1000g water
  • Hot single syrup (open container): 1650g sugar per 1000g water

Boiling Point of Syrup

  • 105°C

Syrup Density

  • Density at 25°C = 1.32
  • Density at the boil = 1.26

Tablet Preparation

  • Solid preparations containing one or more active substances
  • Made by compressively agglomerating a constant volume of particles

Tablet Ingredients

  • Binder: Bonds particles for proper tablet formation
  • Diluents: Used when the active ingredient alone is insufficient for a suitable tablet size
  • Lubricants:Added at the beginning of dry mixing.
  • Disintegrants: Speed up disintegration of tablets
  • Wetting Agents: Ex: Sodium Lauryl Sulfate. Helps in the wetting action of the granules within tablets

Tablet Additives

  • Flavoring: Masks unpleasant tastes/odors
  • Absorbents/Adsorbents: Retain volatile principles.

Granulation

  • Granulation increase powder density, which is crucial for tablet production
  • Granulation is done in a granulator

Tablet Shapes

  • Die (matrice): Hole drilled cylinder shape
  • Punch: Nail-shaped
  • Hopper and hoof: J-shaped

Tablet Machines

  • Reciprocating machine: Lower punch is in a low position before feeding, and the upper is raised during feeding
  • Alternative machine: Hopper and hoof are above the compression chamber before feeding.

Eye Drops

  • Active compound: Stable pH outside normal neutrality range (acidic or basic)
  • pH: Adjusting the pH to a range compatible with tolerance of the eye, between limits of API stability and safety
  • Sterile powder: For dissolution at the time of use if solution unstable

Semi-Solid Preparations

  • Ointments: Hydrophobic or hydrophilic types
  • Gels: Liquids gelled with appropriate gelling agents
  • Creams: Semi-solid, multi-phase application
  • Gargarisms: Liquids for throat gargling
  • Collutoires: Applied to oral mucous membranes for local effect
  • Nasal Preparations: Including drops, sprays, powders, ointments
  • Inhalation Preparations: Used by the respiratory systems for local or systemic effect
  • Suppositories: Fusible, dispersible, or soluble preparations
  • Ovules: Solid preparation intended for local use in the vagina/uterus

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Description

This quiz covers essential concepts related to injectable solutions, including their preparation, pH requirements, and stability. Understand the impact of isotonic solutions on body fluids and the principles of hemolysis. Test your knowledge on the conditions necessary for safe and effective injectable medications.

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