Pharmaceutical Manufacturing - Powders & Tablets

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Questions and Answers

What is the primary focus when considering raw materials for percolation?

  • Availability of materials in the market
  • Conformance to specifications (correct)
  • Cost-effectiveness of materials
  • Brand reputation of suppliers

Which method is NOT mentioned as a way to sterilize equipment?

  • Ultrasonic cleaning (correct)
  • Dry heat
  • Steam
  • Chemical disinfection

What is a critical requirement for water used in the manufacturing process?

  • Must be distilled
  • Must have a high mineral content
  • Needs to be sourced locally
  • Should meet USP requirements (correct)

Which of the following is essential for ensuring the cleanliness of mixing tanks?

<p>Use of appropriate disinfectant dilutions (D)</p> Signup and view all the answers

Which statement best describes the importance of filtration systems in the manufacturing process?

<p>They help in achieving and maintaining sterility by removing contaminants. (D)</p> Signup and view all the answers

Which of the following is classified for oral use?

<p>Syrup (B)</p> Signup and view all the answers

What is the main purpose of an acidifying agent in liquid preparations?

<p>To increase the stability by providing an acidic medium (D)</p> Signup and view all the answers

Which method is NOT used in the preparation of purified water?

<p>Evaporation (C)</p> Signup and view all the answers

Which of the following is NOT a characteristic of solutions?

<p>Stability with all types of active ingredients (A)</p> Signup and view all the answers

What role do humectants play in liquid preparations?

<p>They preserve moisture content (B)</p> Signup and view all the answers

What is the primary function of a co-solvent in liquid preparations?

<p>To extract and suspend other materials without chemical change (D)</p> Signup and view all the answers

Which of the following is an example of an alkalinizing agent?

<p>Ammonia solution (D)</p> Signup and view all the answers

Which solvent is known for being used in most liquid preparations?

<p>Water (A)</p> Signup and view all the answers

What is the primary purpose of diluents in tablet formulations?

<p>To increase the bulk content of the dosage form (C)</p> Signup and view all the answers

Which of the following types of tablets is designed for ease of swallowing?

<p>Caplets (D)</p> Signup and view all the answers

What role do binders play in tablet production?

<p>They glue the tablet ingredients together (A)</p> Signup and view all the answers

Which of these tablet types is specifically formulated to dissolve slowly over time?

<p>Sustained release tablets (A)</p> Signup and view all the answers

What is the primary function of lubricants in tablet manufacturing?

<p>To reduce friction during compression (B)</p> Signup and view all the answers

Which of the following ingredients serves to break the tablet apart upon contact with liquid?

<p>Disintegrants (D)</p> Signup and view all the answers

What type of tablet is designed for administration beneath the tongue?

<p>Sublingual tablets (B)</p> Signup and view all the answers

Which of the following methods is NOT used for large scale preparation of medication?

<p>Levigation with mortar and pestle (C)</p> Signup and view all the answers

Which of the following substances can be classified as an organic solvent?

<p>Isopropyl alcohol (C)</p> Signup and view all the answers

What is the primary function of an antioxidant agent in pharmaceutical solutions?

<p>To prevent chemical oxidation (D)</p> Signup and view all the answers

Which agent is primarily used to optimize the pH of pharmaceutical formulations?

<p>Buffering agent (B)</p> Signup and view all the answers

Which of the following is an example of an anti-microbial agent?

<p>Benzalkonium chloride (D)</p> Signup and view all the answers

What is the role of a thickening agent in pharmaceutical preparations?

<p>To prevent sedimentation (A)</p> Signup and view all the answers

Which substance is widely recognized as a sweetening agent in pharmaceutical products?

<p>No specific examples provided (D)</p> Signup and view all the answers

What is the main purpose of a wetting agent in pharmaceutical formulations?

<p>To reduce interfacial tension (C)</p> Signup and view all the answers

Which of the following agents would be most effective at discouraging foam formation?

<p>Ethylhexanol (D)</p> Signup and view all the answers

What are syrups that contain flavoring agents but no medicinal substances called?

<p>Nonmedicated syrups (B)</p> Signup and view all the answers

Which ingredient is NOT typically found in elixirs?

<p>Sucrose (A)</p> Signup and view all the answers

What is a primary characteristic that differentiates elixirs from syrups?

<p>Elixirs are hydroalcoholic liquids. (D)</p> Signup and view all the answers

Which of the following statements about tinctures is true?

<p>Tinctures generally require light-resistant containers. (D)</p> Signup and view all the answers

What can occur if tinctures are mixed with liquids that have diverse solvent characters?

<p>The solute may precipitate from solution. (B)</p> Signup and view all the answers

Which component is often added to contribute to the stability of an elixir?

<p>Preservatives (C)</p> Signup and view all the answers

What is the opium content in Tincture of Opium compared to Paregoric?

<p>Tincture of Opium is significantly more potent than Paregoric. (A)</p> Signup and view all the answers

What characteristic distinguishes medicated syrups from nonmedicated syrups?

<p>Medicated syrups contain therapeutic agents. (D)</p> Signup and view all the answers

What is the primary objective of using dry granulation methods?

<p>To form granules from powders without using moisture (B)</p> Signup and view all the answers

Which of the following is a method used for dry granulation?

<p>Slugging (D)</p> Signup and view all the answers

What is the role of the Ribbon Mixer Machine in granulation?

<p>To efficiently blend dry powders and granules (A)</p> Signup and view all the answers

What happens during the 'screening of slugs' step in the dry granulation process?

<p>Large tablets are broken down into smaller granules (B)</p> Signup and view all the answers

Which machine is specifically used to improve the compression characteristics of the mixture?

<p>Rapid Mixer Granulator (A)</p> Signup and view all the answers

What characteristic makes the Fluid Bed Dryer Machine essential in the granulation process?

<p>It controls the moisture content in tablet formulations (A)</p> Signup and view all the answers

How do Sigma type blades function in mixing powders?

<p>They rotate in the same direction along a horizontal axis (A)</p> Signup and view all the answers

What is the purpose of using a V-Blender Machine?

<p>To homogenously blend dry powders and granules (A)</p> Signup and view all the answers

Flashcards

Types of Liquid Dosage Forms

Liquid preparations classified by their intended use (e.g., oral, otic, ophthalmic, topical) or their composition (e.g., syrup, elixir, tincture).

Solvent/Co-solvent

Substances that dissolve, suspend, or extract other materials without substantially changing the composition of either the solvent or the material.

Solution Preparation Methods

Solutions are made through heating, mixing, stirring, or using additives like extracts or tinctures.

Humectants

Substances (e.g., propylene glycol, glycerin) to keep liquid products moist and preserve them.

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Acidifying Agents

Substances (like citric acid) that provide an acidic environment for product stability.

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Alkalinizing Agents

Substances (like ammonia solution) that provide an alkaline environment for product stability.

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Purified Water Preparation

Techniques (e.g., distillation, ion exchange, reverse osmosis) for creating purified water for liquid preparations.

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Solution Advantages/Disadvantages

Solutions offer prompt absorption, flexible dosing, and various administration routes, but can have issues with stability, measuring, and taste masking.

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Solvent Types

Solvents can be either organic (containing carbon) or inorganic (lacking carbon).

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Antioxidant Agent

A substance preventing chemical oxidation by oxygen in pharmaceutical products.

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Buffering Agent

Maintains a stable pH in a formulation, ensuring compatibility, stability, and antimicrobial effectiveness, and optimal solubility.

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Antimicrobial Agent

Prevents contamination and growth of microbes, useful in pharmaceutical preparations.

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Wetting Agent

Reduces surface tension between solids and liquids in suspensions for easier mixing

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Anti-foaming Agent

Reduces foam formation in liquids during manufacturing, prevents frothing.

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Thickening Agent (Stabilizer)

Prevents settling or sedimentation of suspended particles, usually in liquids.

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Sweetening Agent

Adds sweetness to pharmaceutical products.

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Percolation definition

A process that involves passing a liquid through a material to extract or separate substances.

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Raw material specifications

Raw materials must meet specific standards for identity, potency, and freedom from contamination.

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Water in manufacturing

Water is crucial in manufacturing and must meet specific standards (e.g., USP requirements).

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Sterilization techniques

Methods like IV sterilization, and ultraviolet sterilization are used to ensure sterility in manufacturing.

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Equipment sanitation

Manufacturing equipment (tanks, filters, piping) must be thoroughly cleaned and sanitized to prevent contamination.

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Nonmedicated Syrups

Syrups containing flavorings but no medicinal substances.

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Medicated Syrups

Commercially prepared syrups combining sucrose, water, flavorings, colorings, a therapeutic agent, and other ingredients.

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Elixirs

Clear, flavored, sweetened hydroalcoholic liquids for oral use, typically less sweet and viscous than syrups.

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Tinctures

Solutions of medicinal substances in alcohol. They are less sweet than syrups, have a characteristic color, and varying degrees of strength.

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Tincture Stability

Tinctures must be stored properly due to their alcoholic content and potential photochemical changes.

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Paregoric

A medicated tincture of opium containing a less potent level of morphine compared to opium tincture, or laudanum.

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Opium Tincture (Laudanum)

A medicated tincture with a higher concentration of opium (and thus morphine) compared to Paregoric.

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Tincture Mixing

Mixing tinctures with liquids of very different solvent characteristics can result in precipitation of the dissolved substance.

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Levigation

A particle size reduction technique where a paste is rubbed against a surface like a mortar or slab using a pestle or spatula.

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Fitzmill Comminutor

A large-scale machine used for particle size reduction, especially for powders and granules.

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Tablet

A solid dosage form, often circular or disk-shaped, designed to be swallowed whole or broken in half.

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Caplet

A tablet shaped like a capsule, made for easier swallowing.

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Diluent

An ingredient that increases the bulk of a tablet, adding volume without changing its medicinal properties.

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Binder

An ingredient that holds tablet ingredients together, giving it structural integrity.

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Disintegrant

An ingredient that breaks the tablet into smaller parts when it comes into contact with liquids, helping it dissolve faster.

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Lubricant

An ingredient that reduces friction during tablet production, allowing it to be easily pressed and ejected from the machine.

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Dry Granulation

A method of granulating powders by compressing them into a solid block, then milling it to create granules. This method is used when heat-sensitive ingredients are present and direct compression is not possible.

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Slugging

A type of dry granulation where the powder is compressed into large tablets called slugs and then milled to create granules. This is more commonly done than the 'precompress' method.

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Precompress

A type of dry granulation where powdered material is compressed using pressure rollers to create a sheet, which is then milled to make granules.

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Ribbon Mixer

A machine used to efficiently blend dry granules and powders homogeneously. It has a ribbon-shaped mixing element that moves through the container.

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Sigma Type Blades

These blades rotate in the same direction along a horizontal axis, used for mixing powders and semi-solid materials.

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Rapid Mixer Granulator

This machine prevents ingredient segregation and improves compression characteristics of the mixture.

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Fluid Bed Dryer

Used in granulation to dry the material, reaching the desired moisture content for tablet formulation granules.

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Double Cone Blender

A machine that mixes dry powders and granules homogenously. It has a cylindrical shell with two conical ends, rotating on its horizontal axis.

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Study Notes

Pharmaceutical Manufacturing - Powders

  • Powders are solid or mixtures of solids, reduced to a finely divided state.
  • Used internally (oral, nasal, insufflation) and externally (topical).
  • Advantages: flexibility in compounding, dose adjustment, good chemical stability.
  • Disadvantages: time-consuming to prepare, potential for dosage inaccuracy, unpleasant taste.
  • Types include: topical, insufflated, medicated, bulk, divided.
  • Bulk powders are often mixed with other materials before administration (e.g., powder for suspension).
  • Small scale powder preparation methods: trituration/comminution, pulverization, levigation.
  • Large scale preparation methods: Fitzmill comminutor, tumbling, mixing/mixer, V-blender.

Pharmaceutical Manufacturing - Tablets

  • Tablets are circular or disk-shaped, can resemble capsules (caplets).
  • Designed to be easier to swallow.
  • Types: compressed, sugar-coated, film-coated, enteric-coated, effervescent, chewable, dispersible, sustained-release, multiple, sublingual, buccal.
  • Excipients include: diluents (increase bulk), binders (glue ingredients), disintegrants (dissolve in water), lubricants (reduce friction).

Pharmaceutical Manufacturing - Granulation

  • Wet granulation is the most common agglomeration process in the pharmaceutical industry.
  • Powder blend is mixed with a granulating liquid.
  • Important steps: weighing/blending, preparing dampened powder/mass, screening dampened powder/mass, drying the granulation, sizing the granulation.
  • Dry granulation: powder mixture is compressed without heat or solvents, least desirable method.
  • Two methods: slugging (repressing), milling.

Pharmaceutical Manufacturing - Granulators & Mixers

  • Rapid Mixer Granulator: prevents segregation of ingredients, improves compression characteristics.
  • Fluid Bed Dryer Machine: granulation process for drying, correct moisture content.
  • Ribbon Mixer Machine: efficient and versatile for mixing dry granules and powders.
  • Double Cone Blender: sigma type blades rotate in the same direction.

Pharmaceutical Manufacturing - Capsules

  • Capsules can be tasteless, odorless, easy to administer, and visually appealing.
  • Hard shell capsules: typically made of gelatin containing dry, powdered ingredients or miniature pellets.
  • Soft shell capsules: primarily for oils or ingredients dissolved/suspended in oils.
  • Ingredients include: gelatin, water, preservatives, colors, opacifiers, flavoring agents, sugars, acids, plasticizers.

Pharmaceutical Manufacturing - Solutions

  • Solutions are liquid preparations with one or more chemical substances dissolved in a solvent.
  • Types include: aqueous (water-based) and non-aqueous (other solvents).
  • Classified by use for: oral, otic, ophthalmic, topical.
  • Classified by composition/use: syrups, elixirs, spirits, tinctures, injections.
  • Solvents: alcohols, glycerin, propylene glycol, water.
  • Ingredients used to increase stability or solubility: antioxidants, buffering agents, antimicrobials.

Pharmaceutical Manufacturing - Manufacturing Considerations

  • Raw Materials: must conform to specifications (identity, potency, free from contaminants).
  • Water: extremely important, and must meet specific USP requirements (e.g., sterilization, quality control).
  • Processes: carefully consider techniques like sterilization, filtration, preventing contamination.

Pharmaceutical Manufacturing - Filling & Packaging

  • Automatic machines: used for filling and sealing bottles, vials, ampoules with appropriate quality control and safety checks.
  • Volumetric filling: delivers premeasured volume to each container.
  • Timed flow filling: determines the fill volume by controlling the time.
  • Gravimetric filling: filling method for viscous products, ensuring consistent volume in each container.
  • Vacuum filling: uses vacuum to control the flow.

Pharmaceutical Manufacturing - Blister Packing

  • Blister packing machines: automatic machines for packing small and regular shaped products like tablets, capsules.
  • Processes involved: blister forming, product feeding, sealing.

Pharmaceutical Manufacturing - Other Equipment

  • Rotary Die Machine: for encapsulating flows by gravity; the process is for the gelatin sheets feeding to the die pocket of the die roll, then being continuously filled with liquid or paste and the sealed capsule cut by the mechanical.
  • Rotary Tablet Press Machines: presses powder to form tablets.
  • Capsule Filling Machine: fills the capsule shell with the desired substance efficiently.
  • High-Speed Automatic Bottle Filling & Cap Sealing Machines: for filling and capping bottles, with various filling capacities per minute.
  • Rotary Bottle Washing Machine: for cleaning and washing.
  • Bottle Unscramblers/Labelling Machines/Carton Machines: for final packaging processing stages, like unscrambling bottles, labeling, and cartonization.

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