Evaluation of Liquid Orals
When a solution contains one or more chemical substances which are soluble and also dissolved in a specified solvent is known as a liquid preparation.In the pharmaceutical industry, the evaluation of liquid orals is an important step to ensure the efficacy, quality as well as safety of the products.
There are various reasons for doing the evaluation of liquid orals such as;
1) Safety of liquid oral dosage forms that may occur with products like impurities, toxicity, or contamination of products.
2) It is also very important to determine the product efficacy, bioavailability, potency as well as stability.
3) The quality of liquid orals should also meet the standards that include purity, uniformity, and stability.
4) By the various health authorities the regulatory standards are set for liquid oral preparations. It is very difficult to meet all the standards set by these authorities.
Evaluation Test for Syrups
The evaluation of syrups is very important to confirm that the formulation that is prepared is high quality, safe, and effective or not. This process is very important for the pharmaceutical industry to maintain regulatory standards.Syrups are the concentrated solution of sugar like sucrose in water or added with other medicinal agents. It is generally used as a flavored vehicle for various medicaments.
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It is commonly enhanced the quantity to include any liquid oral dosage form such as oral suspension in a sweet and viscous vehicle.
It is commonly enhanced the quantity to include any liquid oral dosage form such as oral suspension in a sweet and viscous vehicle.
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For the evaluation of syrups there are following types of tests are performed;
This is done by passing the light through the syrup sample.
Then compared the percentage of light transmission with transmission rates of different grades.
While testing the syrup, you need to be sure that there should not be any fingerprints on the bottle of syrup.
The syrup sample should not contain any bubbles as well as cloudiness.
If any of these will present in the syrup sample then the light that transmits through the sample may diminish due to which the grade of the sample will also be lower.
The first and simple method is to dip a piece of paper into the sample. The paper is filled with chemicals that change the color while dipping into the solution and the color is compared with the list that is given with the paper.
In the second method, the pH meter is used if more accurate results are required. pH meter consists of a measuring glass electrode connected to the electronic meter which measures and displays the reading of pH.
If sucrose concentration in syrup is very high then it may lead to crystallized syrup.
If the sucrose concentration in syrup is less then it may lead to microbial growth.
There is not any specific method for the determination of sucrose in syrup but UV spectroscopy and HPLC may be used for the determination of sucrose in syrups.
Its appearance should be clear means there is no crystallization as well as microbial growth.
The color that is used must be completely soluble with other ingredients used in the preparation.
Its odor and taste must be accepted is should be palatable.
The solid material should be completely miscible in liquid.
Read more - What is Elixir?
The elixir formulations are used to enhance palatability by adding flavors, and also these are the clear, sweetened hydro-alcoholic preparations that are intended to be used for oral administration.
For determining the alcohol content in the elixir the distilling flask is used.
Generally, two to four times the volume of liquid is filled into the distilling flask for heating the solution of the elixir.
The rate of distillation should be maintained so that clear distillates are obtained.
If cloudy distillates are produced then it should be clarified with the help of agitation by using talc, or calcium carbonate then filter the solution.
Now, the temperature of the filtrate is adjusted.
Then with the help of specific gravity, the alcohol content is determined.
Take precautions during the process to minimize the loss of alcohol due to evaporation.
It is assumed that the liquid should contain less than 30% of alcohol.
The measurement of viscosity is one of the important quality control tests in the case of liquid oral dosage forms such as syrups as well as elixirs.
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For the evaluation of syrups there are following types of tests are performed;
(a) Transmittance of Light
A light transmittance meter is used for checking the color of the syrup.This is done by passing the light through the syrup sample.
Then compared the percentage of light transmission with transmission rates of different grades.
While testing the syrup, you need to be sure that there should not be any fingerprints on the bottle of syrup.
The syrup sample should not contain any bubbles as well as cloudiness.
If any of these will present in the syrup sample then the light that transmits through the sample may diminish due to which the grade of the sample will also be lower.
(b) Visual Inspection
In visual inspection, the drug ingredients and final products are examined very carefully for their appearance and purity. For patient acceptance as well as compliance, the physical appearance of the products should be looking good and also appearance should be elegance.(c) pH measurement
In the quality control testing of syrups, the measurement of pH and its maintenance is also a very important step. For the maintenance of pH there are two types of methods are mainly used that are;The first and simple method is to dip a piece of paper into the sample. The paper is filled with chemicals that change the color while dipping into the solution and the color is compared with the list that is given with the paper.
In the second method, the pH meter is used if more accurate results are required. pH meter consists of a measuring glass electrode connected to the electronic meter which measures and displays the reading of pH.
(d) Sucrose Concentration
In the quality control testing of syrups, the determination of the concentration of sucrose is also very important.If sucrose concentration in syrup is very high then it may lead to crystallized syrup.
If the sucrose concentration in syrup is less then it may lead to microbial growth.
There is not any specific method for the determination of sucrose in syrup but UV spectroscopy and HPLC may be used for the determination of sucrose in syrups.
(e) Physical Stability in Syrups
The syrups must be stable physically like;Its appearance should be clear means there is no crystallization as well as microbial growth.
The color that is used must be completely soluble with other ingredients used in the preparation.
Its odor and taste must be accepted is should be palatable.
The solid material should be completely miscible in liquid.
Evaluation of Elixirs
Evaluation of the elixir is important to maintain the safety, efficacy, and efficacy of the elixirs. The elixirs are liquid preparations that contain alcohol or other solvents for dissolving the active ingredients.Read more - What is Elixir?
The elixir formulations are used to enhance palatability by adding flavors, and also these are the clear, sweetened hydro-alcoholic preparations that are intended to be used for oral administration.
Evaluation Parameters
(a) Determination of Alcohol Content
Generally, an elixir contains 5 to 40 percent of alcohol.For determining the alcohol content in the elixir the distilling flask is used.
Generally, two to four times the volume of liquid is filled into the distilling flask for heating the solution of the elixir.
The rate of distillation should be maintained so that clear distillates are obtained.
If cloudy distillates are produced then it should be clarified with the help of agitation by using talc, or calcium carbonate then filter the solution.
Now, the temperature of the filtrate is adjusted.
Then with the help of specific gravity, the alcohol content is determined.
Take precautions during the process to minimize the loss of alcohol due to evaporation.
It is assumed that the liquid should contain less than 30% of alcohol.
(b) Viscosity Measurement
Viscosity is directly related to the resistance to flow. It is a property of liquids.The measurement of viscosity is one of the important quality control tests in the case of liquid oral dosage forms such as syrups as well as elixirs.
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The stability of any liquids or solutions is directly related to viscosity and consistency.
If the viscosity of any liquid may increase then there are huge chances of increased instability.
I hope that you have liked the article on the evaluation of liquid orals. In this article, I have provided all the information related to the evaluation of syrups and elixirs. If you have any point please ask in comment.
The stability of any liquids or solutions is directly related to viscosity and consistency.
If the viscosity of any liquid may increase then there are huge chances of increased instability.
I hope that you have liked the article on the evaluation of liquid orals. In this article, I have provided all the information related to the evaluation of syrups and elixirs. If you have any point please ask in comment.
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