Semi-solid Dosage Forms Overview

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Questions and Answers

Which of the following is the best levigating agent to incorporate a water soluble powder into an oil-in-water (O/W) emulsion base?

  • Propylene glycol
  • Mineral oil
  • Glycerin (correct)
  • White wax

A pharmacist wants to incorporate a water-soluble drug into a water-removable base. Which of the following levigating agents would be most appropriate?

  • Mineral oil
  • Propylene glycol
  • White wax
  • Glycerin (correct)

What is the primary purpose of a stiffener in an ointment base?

  • To enhance the viscosity of the preparation (correct)
  • To decrease the evaporation rate of water from the preparation
  • To increase the rate of drug penetration through the skin
  • To act as a preservative to prevent microbial growth

Which of the following is considered a humectant?

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

A pharmacist wants to increase the absorption rate of a drug through the skin. What type of excipient might they add to the formulation?

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

Why is it difficult to incorporate oil-soluble ingredients into an O/W emulsion base?

<p>All of the above (D)</p> Signup and view all the answers

Which of the following is NOT a characteristic of a good levigating agent?

<p>Should have a high melting point (B)</p> Signup and view all the answers

What is a key characteristic of hydrocarbon bases when applied to the skin?

<p>They offer an emollient effect. (C)</p> Signup and view all the answers

Which of the following is an example of an absorption base that can incorporate aqueous solutions?

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

How much water can typically be incorporated into absorption bases like lanolin?

<p>50% of their volume (C)</p> Signup and view all the answers

What primary ingredient makes up yellow ointment?

<p>Yellow wax and petrolatum (C)</p> Signup and view all the answers

What is a noted difficulty when working with hydrocarbon bases?

<p>They cannot support aqueous solutions. (D)</p> Signup and view all the answers

What is a primary benefit of topical delivery of pharmaceuticals?

<p>Avoids first-pass gut and hepatic metabolism (D)</p> Signup and view all the answers

Which formulation is most suitable for dry, scaly skin?

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

Which of the following is NOT an advantage of topical formulations?

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

For which condition would an anti-pruritic topical medication be most appropriate?

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

What is a key feature of a lotion compared to an ointment?

<p>Used for intertriginous areas (B)</p> Signup and view all the answers

Which property should topical dermatological formulations ideally NOT have?

<p>Alters membrane functioning (D)</p> Signup and view all the answers

What function do topical medications designed to provide hydration achieve?

<p>Hydrate or provide an emollient effect (B)</p> Signup and view all the answers

Which route of administration is NOT typically associated with topical application?

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

Which of the following is NOT a type of semisolid dosage form?

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

What is a characteristic of oleaginous bases used in ointments?

<p>They are greasy and do not absorb water. (B)</p> Signup and view all the answers

Which method is NOT typically used for the preparation of ointments?

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

Which of the following statements accurately describes the advantages of semisolid dosage forms?

<p>They provide localized treatment with reduced side effects. (C)</p> Signup and view all the answers

Which semisolid dosage form is most likely to provide a cooling sensation upon application?

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

Which of the following methods is used to mix the ingredients of ointments?

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

What is an example of a water-soluble ointment base?

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

Which type of semisolid dosage form is most suitable for delivering medication in a more viscous mixture?

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

What role does sodium lauryl sulfate play in the formulation of water-removable bases?

<p>It serves as the emulsifying agent. (C)</p> Signup and view all the answers

Which of the following is NOT a characteristic of water-soluble bases?

<p>They absorb water effectively. (D)</p> Signup and view all the answers

In the formula for Hydrophilic Petrolatum, USP, what is the total weight of oleaginous components?

<p>860 g (C)</p> Signup and view all the answers

What is the likely form of PEG with an average molecular weight above 1000?

<p>A wax-like white material (A)</p> Signup and view all the answers

Which of the following accurately describes the properties of oleaginous bases?

<p>They are high in viscosity. (A)</p> Signup and view all the answers

What does the term polypropylene glycol indicate in a water-removable base?

<p>It is an aqueous phase component. (D)</p> Signup and view all the answers

Which of the following is an example of a water-soluble ointment base?

<p>Polyethylene glycol ointment (C)</p> Signup and view all the answers

What is the purpose of a levigating agent when incorporating a drug into an oleaginous base?

<p>To wet the powder before incorporation. (C)</p> Signup and view all the answers

What is the primary purpose of using stiffeners in ointment preparation?

<p>To enhance the viscosity of a preparation (D)</p> Signup and view all the answers

Which method involves using a mortar and pestle for uniform ingredient mixing?

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

What type of agent is typically used for bases where oils are the external phase during levigation?

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

What does the process of fusion in ointment preparation involve?

<p>Melting components and stirring until congealed (A)</p> Signup and view all the answers

Which of the following is NOT a manual method of ointment preparation?

<p>Utilizing electronic mortars and pestles (C)</p> Signup and view all the answers

What is the role of a levigating agent in the incorporation process?

<p>To mix solid material in an insoluble vehicle (C)</p> Signup and view all the answers

Which of these statements regarding heat-labile substances during fusion is true?

<p>They are added last to prevent degradation. (C)</p> Signup and view all the answers

What is a common characteristic of the mechanical methods of preparation in ointment formulation?

<p>They are faster than manual methods. (C)</p> Signup and view all the answers

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Flashcards

Oleaginous Bases

Hydrocarbon bases that have emollient and occlusive properties on skin.

Examples of Oleaginous Bases

Common examples include White Petrolatum and Yellow Ointment.

Absorption Bases

Bases that can incorporate aqueous solutions, forming water-in-oil emulsions.

Water-in-Oil Emulsions

Emulsions allowing significant water incorporation, like lanolin.

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Emollients

Substances that soothe and protect the skin, often found in bases.

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Topical Delivery

Administration of medications via skin application.

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Ointments vs. Creams

Ointments are for dry skin; creams are for oozing areas.

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Advantages of Topical Formulations

External use, avoids first pass metabolism, and reduces side effects.

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Disadvantages of Topical Formulations

No accurate dosing and potential oxidation of the base.

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Therapeutic Uses of Dermal Applications

Used for anti-fungal, anti-bacterial, analgesic, and more.

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Functions of Topical Pharmaceuticals

Protect, hydrate, and deliver medication to skin.

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Emollient Effect

Softens skin and provides hydration.

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Intertriginous Areas

Areas where skin rubs together; requires special care.

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Levigating agent

A substance used to help incorporate drugs into a base more smoothly.

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Mineral oil

A levigating agent suited for oleaginous bases.

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Water-soluble drugs

Drugs that can dissolve in water for incorporation into bases.

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O/W emulsion base

A type of emulsion where oil is dispersed in water.

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Stiffeners

Substances like waxes that increase the viscosity of a preparation.

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Humectants

Ingredients that reduce evaporation rate of water.

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Penetration enhancers

Agents that increase the absorption rate of drugs through the skin.

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Incorporating oils in water miscible bases

Mix oils with glycerin or propylene glycol before adding to the base.

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Semi-solid dosage forms

Pharmaceutical preparations like ointments, creams, and gels applied topically.

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Ointment

A semi-solid preparation used for topical applications, can be medicated or unmedicated.

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Creams

Emulsified semi-solid dosage forms that can be either W/O or O/W, used for topical use.

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Two methods of ointment preparation.

Incorporation of solids and fusion methods for preparing ointments.

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Therapeutic use of semi-solid forms

Targeted delivery of medication through the skin for local effects.

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Quality control in semisolids

Ensuring consistency, efficacy, and safety of semisolid pharmaceutical preparations.

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Antioxidants

Substances that delay rancidification in oils.

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Manual Methods of Preparation

The use of tools like a mortar and pestle to mix ingredients.

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Incorporation

Mixing components to achieve a uniform preparation.

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Fusion

Melting components together and then cooling with stirring.

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Levigating

Mixing solids in a vehicle where they are insoluble.

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Pulverization by Intervention

Method to incorporate gummy materials by grinding.

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Electronic Mortars and Pestles

Mechanical devices used for efficient mixing of ingredients.

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Hydrophilic Petrolatum

An ointment base that incorporates water-soluble drugs.

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Aquaphor

A commercial product of hydrophilic petrolatum used to include water-soluble drugs.

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Water-Removable Bases

Ointment bases that are washable and allow for incorporation of drugs.

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Sodium Lauryl Sulfate

An emulsifying agent used in water-removable bases.

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Polyethylene Glycol (PEG)

A water-soluble base used for drug incorporation, does not contain oleaginous components.

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PEG Numeric Designations

Indicate average molecular weight, e.g., PEG300, PEG3000.

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Incorporation of Drugs

The process of mixing drugs into ointment bases using levigation.

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Oleaginous Bases Properties

Anhydrous, not dissolvable or miscible in water, and generally high viscosity.

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Study Notes

Semi-solid Dosage Forms

  • Semi-solid dosage forms include ointments, pastes, creams, gels, plasters, and glycerogelatins.
  • They are topically applied through the skin and are used for external applications.
  • Ophthalmic ointments/gels are also available, and other routes include rectal, vaginal, and nasal administration.

Learning Objectives

  • Enlist types of semi-solid dosage form and routes of administration.
  • Enlist therapeutic uses of semi-solid dosage form.
  • Explain dermatological preparation, discussing functions of topically applied semi-solids and providing three examples.
  • Enlist six advantages and two disadvantages of semi-solid dosage forms.
  • Discuss properties of semi-solid dosage forms.
  • Understand ointment use, including both medicated and unmedicated ointments.
  • Classify ointment bases, providing examples of four types (oleaginous, absorption, water-removable/emulsion, and water-soluble/water-miscible).
  • Discuss drug incorporation in four types of ointment bases.
  • Describe excipients used in semi-solid preparations.
  • Describe two methods of ointment preparation and two techniques for mixing ingredients.
  • Compare and contrast ophthalmic and topical ointment bases.
  • Explain quality control, storage, packaging, labeling, and beyond-use dates (BUD) for ointments.
  • Differentiate between ointments, pastes, creams, and gels.
  • Compare four types of ointment bases.
  • Discuss various terms associated with semi-solid dosage forms.

Properties of Semi-solid Dosage Forms

  • Smooth texture, elegant appearance
  • Non-dehydrating, non-greasy, non-staining.
  • Non-gritty and non-irritating.
  • Do not alter membrane/skin functioning.
  • Miscible with skin secretion.

Ointments

  • Intended for external application to skin or mucous membranes.
  • Unmedicated ointments function as protectants, emollients, or lubricants. (Examples: cold cream, lip balm).
  • Ointment bases serve as vehicles for medicated ointments used topically (e.g., for antipruritic, keratolytic, and astringent effects).

Ointment Bases

  • Four types based on physical composition: oleaginous, absorption, water-removable/emulsion, and water-soluble/water-miscible.

  • Oleaginous bases: hydrocarbon bases, used as emollients, occlusive dressings. Examples: White petrolatum, Yellow ointment

  • Absorption bases: water-in-oil emulsions (can incorporate up to 50% water). Examples: hydrophilic petrolatum, Aquaphor.

  • Water-removable/washable bases: oil-in-water emulsions (easily washed from skin). Example: Hydrophilic Ointment, USP.

  • Water-soluble bases: do not contain oleaginous components. Example: Polyethylene glycol (PEG) ointment.

Creams

  • Contain one or more medicinal agents in a W/O or O/W emulsion or water-washable base.
  • Opaque, soft solids, or thick liquids for external application.
  • Vanishing creams are oil-in-water emulsions with high water percentages.

Gels

  • Semisolid systems of dispersions of inorganic particles in an aqueous liquid vehicle, rendered jellylike by a gelling agent.
  • Gelling agents include synthetic macromolecules (e.g., carbomer 934, cellulose derivatives), and natural gums (e.g., tragacanth).
  • Contains solvents (e.g., alcohol, propylene glycol).
  • Contains preservatives (e.g., parabens) and stabilizers (e.g., edetate disodium).

Pastes

  • Thick and stiff, do not flow at body temperature; larger proportion of solid material.
  • Intended for application to the skin and absorb serous secretions.
  • Example: Zinc oxide paste (Lassar's plain zinc paste).

Plasters

  • Solid or semisolid adhesive masses spread on a backing (e.g., paper, fabric, moleskin, plastic).
  • Applied to the skin for prolonged contact, protection, or mechanical support.
  • Example: Salicylic acid plaster for removing corns.

Glycerogelatins

  • Plastic masses containing gelatin, glycerin, water, and an added medicinal substance (e.g., zinc oxide).
  • Melted before application, cooled slightly, and applied to the affected area.
  • Example: Zinc gelatin boot used for varicose ulcers.

Practice Questions

  • Multiple practice questions pertain to semi-solid preparations, their properties, advantages, disadvantages, components, manufacturing methods, uses, and various aspects related to quality control and storage.

Incorporation of Drugs

  • Methods for incorporating various types of drugs into semi-solid bases.
  • Levigating.
  • Fusion.

Lab Scale and Large-Scale Equipment

  • Methods for manufacturing semi-solid dosage forms.

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