Monophasic liquid dosage form

Pharmaceutics 1st

Monophasic liquid dosage form

The Monophasic liquid dosage form is a liquid preparation containing two or more components in one phase system. It is represented by a true solution.

A true solution is a clear homogenous mixture that is prepared by dissolving a solute in a suitable solvent. The component of the solution which is present in large quantities is term as solute.

Classification of monophasic liquid dosage form

Monophasic liquid dosage form classified into two groups.

For internal use                                                                                   For external use  

Mixtures                                                    Apply on skin                 Use in mouth           Insert in the body cavity

Syrup-                                                                      – Liniment                          – Gargles                             – Douche

Linctuses-                                                               – Lotion                               – Mouthwash                      – Eardrop

Elixirs-                                                                                                                  – throat paint                      –  Nasal spray

Droughts-                                                                                                                                                           – Nasal drop

Paediatric drops

 

The monophasic liquid dosage form the solution is prepared by three methods.

  • Dissolution
  • Chemical reaction
  • Extraction

The dissolution method is commonly used for monophasic liquid preparation

Gargles –

Monophasic liquid dosage form

Gargles are aqueous solutions mainly used to prevent or treat throat infections. They are available in concentrated form with direction for dilution with warm use the medicaments are in close contact with the mucus surface of the threat by gargling the solution.

For antibacterial activity phenol or thymol is generally added in small concentrations.

Example – Potassium Chloride and phenol glycerine BPC

  • Potassium chloride – 30.0 g
  • Patent blue – 0.009 g
  • Liquefied phenol – 15.0 ml
  • Water sufficient to make – 1000 ml

Method of preparation

Take potassium chloride and dissolve in warm water cocl and add liquefied phenol add the dye solution filter and make up the volume transfer to a container, cork, label and dispense.

Container – Clear glass bottles with plastic screw cap. A Colour bottle is required to be used if protection is required

Labeling – “For external use only” and proper dilution instruction should be written on the label.

Storage – Gargles are supplied in Well closed airtight glass container.

Monophasic liquid dosage forms

Mouthwashes –

Monophasic liquid dosage form

 these are the non-sterile aqueous solution with pleasant test and odor use for oral hygiene and to treat infections of the mouth.

Mouthwashes contain antibacterial agents, alcohol, glycerine, sweetening agents, flavoring agents, and coloring agents.

Example – Compound sodium chloride mouthwash BPC

  •  Sodium chloride – 15 g
  •  Sodium Bicarbonate – 10 g
  •  Peppermint water to produce – 1000 ml

Method of preparation – dissolve the weigh quantity of sodium chloride and sodium bicarbonate in 3/4 th of the peppermint water. Add more peppermint water to produce the required volume transfer to a bottle label and dispense.

Container – White fluted bottles

Labeling – proper direction for mouthwash dilation must be mention for example” for external use only” provided in the pH range of 5 to 9.5. Not to be swallowed in a large amount.

Direction – Dilute 20 times its volume with warm water before use as a mouthwash.


Throat Paints – 

Monophasic liquid dosage form

It is a viscous liquid preparation used for mouth and throat infection. ThroatPaints are viscous due to high contact of glycerine which being sticky adhere to the affected site. And prolong the action of medicaments commonly used throat Paints are phenol glycerine, tannic acid glycerine compound iodine Paints.

Example – compound iodine paint

  • Potassium iodide  – 25.0 g
  • Iodine – 12.5 g
  • Alcohol 90%  40.0 ml
  • Water – 25.0 ml
  • Peppermint oil – 4.0 ml
  • Glycerine to produce – 1000 ml

Method of preparation – potassium iodide is dissolved in water. Iodine is added to the concentrated potassium. Iodide solutions to form kI3. Peppermint oil is dissolved in alcohol 90% of v/v. And add the alcoholic solution is added to the iodine solution volume is made up of glycerine.

Container – a wide mouth fluttered, light-resistant, screw cap, the glass jar is used. dispense in amboured colour bottle.

Direction – apply with the help of a soft brush or a cotton swab. Food and water before and after applications of throat paint. It should be avoided for 1 hour

Labeling – For external use only, store in a cool place

Monophasic liquid dosage forms

Ear drops-

Monophasic liquid dosage form

These are the solution used for the installation into the ear. The solution is prepared in water glycerine, propylene glycol, or alcohol. A vehicle like glycerine and propylene glycol are preferred as By increases contact time and softens the wax.

Ear drops mainly give following of action.

Antibacterial

-Softening the wax

-Mild infections

Example – Sodium Bicarbonate eardrop

  • Sodium Bicarbonate  –  5 gram
  • Glycerine –    30 ml
  • Purified water up to    –   200 ml Jindagi

Papa  Prepare eardrop

Direction – place 2-3 drops in each ear as directed.

Container – ear drop should be placed in colored. Fluted glass bottle and supplied with a dropper.

Labeling

  • For external use only.
  • NOL for injection.
  • Discontinue the use if irritation persists.

Storage- Store in a cool place.

Monophasic liquid dosage forms

Nasal drop-

Monophasic liquid dosage form

These are the aqueous solution used for installation into the nostril. The oily vehicles are not used because they inhibit the movement of cilia and produce lipoid pneumonia. These are the preparations isotonic with blood plasma phosphate buffer of PH 6.5 is used as a vehicle. Nazar drops mainly used for nasal decongestion.

Example – ephedrine nasal drop B.P.C

  • Ephedrine –  0.5 g
  • chlorobutol  – 0.5 g
  • Sodium chloride  –  0.5 g
  • Water – qs

Direction – Place 2 to 3 drops in each nostril as directed

Container – Nasal drop should be packed in a colored, fluted glass bottle and supplied with a dropper.

Labeling – For external use only

Storage – Nasaldrop is supplied in a well-closed glass container in a cool place.


Enemas – 

Enema

An enema is an introduction of fluid into the lower bowel through the rectum for the purpose of medication or nourishment

Purpose – To stimulate defecation and to treat constipation

To administer medication

To destroy the Nagpurintestinal parasite

To relieve the gaseous distention

Classification of enema – 1. Evacuant enema       

2.Ratained enema

1. Evacuant enema   –  

it is the rectal enemas employed to promote evacuation of bowel and to clean the Colon for retention and for diagnosis.

Purpose – To stimulate defecation and to treat constipation.

– To relieve the gaseous distension by stimulating peristalsis.

– to stimulate uterine contraction and to hasten childbirth.

Evacuant enema again classified into following types.

  • simple evacuate enema
  • medicated evacuent enema — Oil enema

-Purgative enema

– Astringent enema

– Anthelmintic enema

– Carminative enema

2. Retained enema –

in this enema, a number of solutions are administered rectally for the local effects of the medication.

There are five types of Retained enema.

– Stimulant enema

– Nutrient enema

– Emollient enema

– Sedative enema

– Anesthetic enema

Container – single-use plastic back with rectal nozzle.

Label – to be warmed to body temperature before use

Storage – Store in a cool and dark place


Syrups – 

syrup

syrup is a viscous concentrated solution of sucrose and other sugars with or without medicaments. It’s a liquid dosage form taken to the oral route. Flavoring agent used as a vehicle. Contain up to 85% to resist bacterial growth.

Components used for the preparation of syrup

– sucrose or other substitutes (glycogenic or nonglycogenic)

– nonglycogenic- methylcellulose, hydroxyl methylcellulose

Colouring agents – Green – mint

Brown – chocolate

Red – amaranth

Preservatives – methyl hydroxybenzoate

Propyl hydroxybenzoate

Chlorocresol sorry movie

Benzoic acid

Phenyl mercuric nitrate

Advantages of syrup – 

  1. Ability to avoid the bad taste of medication
  2. The Thick Character of the syrup has a soothing effect on irritated tissue of the throat
  3. Contain little or no alcohol
  4. Easy to adjust the dose for child’s weight.

Disadvantages of syrup – 

  1. Formation of invert sugar
  2. Affect the taste and stability

Classification of syrup – 

1. Simple syrup – water is used alone for making syrup. e.g sucrose syrup

2. Medicated syrup – containing medical agents. e.g Ipecac syrup, cough syrup.

3. Flavoured syrup – containing flavoring agents but not medicinal substances vehicle or flavor for or prescription.

e.g Cherry syrup, Raspberry syrup

Monophasic liquid dosage forms

Simple syrup IP

Sucrose  – 66 7.0 gram

Purified water QS – 1000g

Method – add sucrose to purified water and hate it too to dissolves sucrose with occasional stirring. Cool it and add more purified water to make the final required volume.

By process of extraction – tolu syrup IP

Tolu halsam – 12.5g

Sucrose – 660.0g

Purified water – 1000.0g

Container – Glass bottles fitted with white polypropylene molded or black thermosetting plastic screw closer

Storage – Temperature should be maintained

– No more air phase in the surface of product growth of microorganism.


Elixir

Elixir is a clear, sweet, and flavor hydroalcoholic liquid preparation intended for use. The main ingredients of Elixir are ethyl alcohol(5.40%), water glycerine or propylene glycol, flavoring agents, coloring agents and some suitable preservatives.

Components – vehicles, Medi comments, sweetening agent, preservative, coloring agent, flavoring agent

Vehicles – alcohol, water, glycerine sorbitol, propylene glycol, syrup.

Preservatives – Chloroform (1.1) is used in the form of double-strength alcohol concentration.

Sweetening agent – Glycerol, sorbitol, propylene glycol, sodium saccharide

Colouring agent – amaranth ( magenta red ) compound tetrazine (saffron )

Green s and tartrazine green.

Flavouring agent – fruit Flavour

Type of elixirs 

Non-medicated elixirs

They are simple elixirs that do not contain medicated agents. These only contain alcohol, sweetening agents, colouring agents they are self preserving.

Medicated elixirs – Medicated elixirs are a solution of the active ingredient dissolve in water and an alcohol often along with other excipients such as preservatives.

 

Method of preparation –

-Water-soluble ingredients are dissolved in part of water + dissolve sucrose

– dissolve other ingredients in alcohol

– aqueous solution + alcoholic solution

– stir properly — make up the volume with solvent or vehicle.

– sucrose increases viscosity but decreases the solubility properties of water and so must be after primary solution has been carried out.

-elixirs should be brilliantly clear and therefore stain or filter.

 

Example – dissolve the piperazine citrate in part of the purified water, add the orange oil, glycerine, syrup, chloroform spirit, and sufficient purified water to produce the required volume.

Storage – Elixirs should be store in a tightly closed and light-resistant container away from direct heat and sunlight.

Container – Elixirs are supplied in well field, air tight glass bottles having screw caps are suitable plastic bottles.


Liniments – 

liniments are solutions or mixtures of various substances in oil, alcoholic solutions of soap, or emulsions and may contain suitable antimicrobial preservatives.

These preparations that may be liquid or semi-liquid are intended for external application and should be so labeled.

They are rubbed onto the affected area because of this there was also call embrocation. They are applied with friction and rubbing on the skin. Oil or soap base providing for ease of application and massage.

Types of liniments – 

Alcoholic liniment – alcohol helps in the penetrating of Medicaments into the skin and also increases its counter irritants and rubefacient action.  e.g soap liniment,aconite liniment.

Oily liniments – Arachis Oil and cottonseed oil are used which spread more easily. e.g camphor liniments, methyl liniments.

Container – liniments are distance in color fluted bluebottles.

Labeling – For external use only. Not to be applied to open wounds or broken skin.

Storage – liniments should be stored in a tightly closed air-tight container in a cool place.

Preparation – it can be prepared as solution or emulsion method

Example – Turpentine liniment IP

Soft soap – 90g

Camphor – 50g

Turpentine oil( freshly rectified)  – 650ml

Purified water – 1000ml

Method – Mix the soft soap with a small quantity of water, prepare a solution of camphor in the freshly rectified turpentine oil. Gradually add the camphor solution to the soap mixture with trituration still a thick creamy emulsion is formed. Add sufficient purified water to produce the required volume. Makes it thoroughly transfer the preparation to a bottle, label it.


Lotion –

these are liquid or semisolid preparation meant for external application to the skin without friction. They are applied to the skin with the help of some absorbent material such as cotton, wool, or gauze soaked in it.

Lotions may contain antimicrobial preservatives and other appropriate excipients such as stabilizers lotions are intended to be applied to the unbroken skin without fiction.

The uses of alcohol hasten to dry and enhance cooling. The use of glycerine keeps skin moist and promotes adherence and Residue powder on the skin.

Container – lotions should be dispensed in color fluted bottles close with a plastic screw cap.

Labeling – the container should be a label for external use only and shake well before use.

Example – calamine lotion IP

  •   Calamine   –  150g
  •   Zinc oxide  – 50g
  •   Bentonite – 30g
  •   Sodium citrate – 5g
  •   Liquefied phenol – 5ml
  •   Glycerine  – 50ml
  •    Rose water qs   – 1000ml

Method – Dissolve sodium citrate in rose water. Triturate the Calamine, zinc oxide and bentonite with a solution of sodium citrate. At the liquefied phenol. Add the glycerine. Add purified water in sufficient quantity to produce the required volume transfer the lotion to a bottle and label it.


DOSAGE FORM

 

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