Physical and Chemical Factors Influencing the Chemical Degradation of Pharmaceutical Product: Temperature, Solvent, Ionic Strength, Dielectric Constant, Specific & General acid base catalysis : Pharmaceutical Guidelines -->

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Physical and Chemical Factors Influencing the Chemical Degradation of Pharmaceutical Product: Temperature, Solvent, Ionic Strength, Dielectric Constant, Specific & General acid base catalysis

Pharmaceutical products are medicines prepared for human use and are called pharmaceutical products.
Pharmaceutical products are medicines prepared for human use and are called pharmaceutical products. These are chemically prepared with specific formulation and controlled by pharmaceutical legislation (authorized). Different brands or pharmaceutical companies prepare them in different packaging. On the other hand, chemical degradation is the process that breaks a chemical molecule into small chemicals. It is also called chemical decomposition or thermal decomposition. This affects the pharmaceutical value of the drug.

Some external factors can influence the degradation of a pharmaceutical product. These factors are physical and chemical in nature. In this article, the specific influences are discussed critically. This can show a precise pharmaceutical application and degradation procedure.

Influence of the External Factors

External factors present the environmental reasons that show effects on the particular system of a pharmaceutical product. These factors are,
  • Temperature
  • Solvent
  • Ionic Strength
  • Dielectric Constant
  • Acid-Base Catalyst

Temperature

When a specific amount of temperature is applied to a pharmaceutical product, then it starts to activate the molecules inside. According to the collision theory, the high temperature starts the collision between the chemical molecules of the product. Overall, it increases the chemical degradation of a pharmaceutical product. On average, every reaction becomes two to three minutes faster with every 10-degree increase in temperature. With the increase in temperature, the chemical composition of a compound breaks down to its molecular level. This decreases the ability of the compound and increases the rate of degradation of the compound.

This is one of the reasons that pharmaceutical products or medicines are suggested to keep in cold places. It is most preferable to have cold storage in the pharmaceutical industry. In this way, the medicines become safe and best applied.

Solvent

A solvent is defined as any chemical compound that is capable of dissolving any other substance without changing the chemical nature of the substance or the solvent itself. Solvents are classified into two types. Aqueous solvent or inorganic solvent, which includes water, and non-aqueous or organic solvent, which includes alcohol, glycerine, and polyethylene glycol. Solvent has a significant influence on the rate of degradation of a drug. The effect of the dielectric constant and viscosity of a solvent can alter the rate and mechanism of a chemical reaction. The effect of the dielectric constant on the degradation of a chemical compound is already under resource with different chemicals, which include aspirin, phenoxybenzamine, triprolidine, and levofloxacin. Besides, it is also recorded that the rate constant and viscosity of a solvent has a linear relation to the degradation of the chemical substance. The selection of a particular solvent and cosolvent is essential for the stability and degradation of any pharmaceutical formulation. Different factors must be considered before selecting a solvent. These factors include the chemical nature of the substance, the polar character of the substance, and the behavior of the drug on a particular medium. The solubility of a compound is calculated in values of kobs. The kobs value for water is recorded as 78.5, and the kobs value of ethylene acetate is recorded as 6.0. The value of kobs depends on the viscosity and dielectric constant of the compound.

Ionic Strength

A charged ion holds an inactive strength state. This is transferable and applied in a different reaction. It influences the chemical degradation of a pharmaceutical product. For example, if two reactants are A and B. Their charges are z1 and z2. Then the internal chemical equation will look like,

Az1 + Bz2 = [A……B](z1+z2)

Overall, the ionic strength will show its effect between the charges. This can also influence the chemical degradation level in a pharmaceutical product. On the other hand, this can be calculated for further precaution and essential storage procedures. Eventually, it helps to build a proper supply chain of safe and secure medicine. This strength differs with the product and formulation intensity of the medicine. This will be documented in different phases, such as laboratory trials of medicine.

Dielectric Constant

Every electric field holds some energy in it for further transfer or transformation. The measuring unit of this stored energy is the dielectric constant. This is calculated through a ratio of permeability of the material to the electric permeability of free space. This shows an essential strength factor in an electric field. This effect can be calculated through,

In k = In kE=.infinity. – NzAzBe2 / RTr|E

This equation can help to calculate the intensity or effect of the Dielectric constant in the chemical degradation of pharmaceutical products. It also depends on some chemical factors that are associated with the overall degradation reaction.

This image shows the connection between Dioxane, Dielectric constant, and Rate Constant. This presents the overall effectiveness of the procedure. On the other hand, it helps in the practical calculation of the present materials. Overall, this section presents the quantitative analysis of the dielectric constant in the chemical degradation of the pharmaceutical product.

Acid-Base Catalyst

A catalyst is a chemical molecule or substance that increases the speed of the reaction but remains unchanged till the end. In that case, it does not affect the overall temperature change in the reaction, delta G.

This calculation can show the quantitative measurement of the overall temperature change into the reaction that remains zero in terms of catalyst effect.

Acid-base catalyst is one of the categories that present the presence of an acid or base. That molecule will improve the overall speed of the reaction. In this way, the acid-base catalyst will be effective in overall chemical degradation.

The time of degradation of any pharmaceutical product is mentioned on the packing of the product. Different physical and chemical factors are noted and calculated for determining the rate of degradation of a chemical substance. The pharmaceutical companies have introduced special departments for ensuring, calculating, and determining the rate of degradation of a chemical compound. In the article, we were introduced to such factors that help in the easy determination of the rate of degradation of a chemical compound. These factors include acid-base catalyst, temperature, solvent, dielectric constant, and ionic strength.
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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