How Can Drug Stability Be Improved?

What is a stable drug?

The term drug stability refers to the extent to which a drug substance or product retains, within specified limits and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of its manufacture..

How does temperature affect drug stability?

When a drug is stored in temperatures that are too high or too low, the drug’s chemical stability will likely be impacted. That means that the drug may degrade and form impurities. While these impurities may not be visually noticeable, this degradation can cause real problems when the drug is administered.

What is drug oxidation?

Drug metabolism is the term used to describe the biotransformation of pharmaceutical substances in the body so that they can be eliminated more easily. … Drugs are metabolized through various reactions including: Oxidation. Reduction. Hydrolysis.

What is an example of stability?

Stability is the state of being resistant to change and not prone to wild fluctuations in emotion. An example of stability is a calm, stable life where you don’t have wild ups and downs. The condition of being stable or in equilibrium, and thus resistant to change. The tendency to recover from perturbations.

What affects drug stability?

Common factors that affect this stability include temperature, light, pH, oxidation and enzymatic degradation. Special considerations are also required when dealing with chiral molecules, deuterated internal standards and large biomolecules.

How can we prevent drug degradation?

Use of surfactant-based systems such as micelles can reduce the hydrolysis of hydrophobic drugs. Alternatively, preparing a suspension reduces the amount of drug in solution and hence may increase stability. A lyophilized product will remove water and significantly reduce the rate of hydrolysis.

Why is drug stability important?

Stability is an essential quality attribute for pharmaceutical formulations. Evaluation of drug stability can prevent toxicity and increase safety, efficacy and quality of the final drug product. In this work, various factors affecting stability of both small molecule and biopharmaceutical compounds were investigated.

What properties can affect the shelf life of drug?

Stability of drugs depends on both environmental factors such as temperature, air, light and humidity, and drug-related factors such as the active ingredient itself, the dosage form (tablet, solution, etc.) and the manufacturing process.

How can you improve stability?

Let’s take a look at 5 ways you can increase your stability.Single-Leg Movements. It’s easy to be stable on both legs, but take one leg away and you reveal the true value of your lower body and pelvic stability. … Bridge Variations. … Unstable Surfaces. … Core Strength. … Glute Activation.

What is physical instability?

Physical instability of amorphous APIs is a complex problem and the major limitation which impedes the wider application of amorphous products in a common practice. … It is obvious that the successful implementation of amorphous drug is strictly related to the problem how to control its crystallization ability.

How can you prevent oxidation for drug stability?

Despite oxidation being a relatively common pathway for drug decomposition, it has not been studied in as much detail as hydrolysis since oxidative degradation can often be reduced to acceptable levels by storing susceptible drugs in the absence of light (eg, use of amber vials) and oxygen (eg, store under nitrogen or …

What are the types of stability?

8.1 Different types of stabilityFreeze and Thaw Stability,Bench-Top Stability,Long-Term Stability,Stock Solution Stability,Processed Sample Stability.

What is real time stability?

In real-time stability testing, a product is stored at recommended storage conditions and monitored until it fails the specification. In accelerated stability tests, a product is stored at elevated stress conditions (such as temperature, humidity, and pH).

Why is suspension unstable?

All suspensions, including coarse emulsions, are inherently thermodynamically unstable. They will, through random motion of the particles over time, aggregate because of the natural and dominant tendency to decrease the large specific surface area and excess surface energy.

What is suspension stability?

It is important to understand that suspensions are kinetically stable, but thermodynamically unstable, system. Physical stability is defined as the condition in which the particles remain uniformly distributed throughout the dispersion without any signs of sedimentation.

What is the stability?

1 : the quality, state, or degree of being stable: such as. a : the strength to stand or endure : firmness. b : the property of a body that causes it when disturbed from a condition of equilibrium or steady motion to develop forces or moments that restore the original condition.

Is aspirin sensitive to moisture?

It has long been known that moisture affects the stability of some drug substances. Aspirin is a classical example. Aspirin is not wet granulated. Even though the water is driven off in a wet granulation, there is still sufficient moisture stress in the process to induce excessive decomposition on subsequent storage.

How do you determine drug stability?

Stability Testing for Drug Substances and ProductsPhysical: Appearance, melting point, water content, clarity and colour of solution, pH, dissolution and disintegration characteristics, viscosity, crystal modification or particle size.Chemical: Assay, degradation products, related substances and residual solvents.More items…

How do you perform a stability test?

7 Steps for Stability TestingStep 1: Batch Production. … Step 2: Product Container Filling. … Step 3: Initial Test (Time Point Zero). … Step 4: Product Storage. … Step 5: Product Evaluation. … Step 6: Determine Stability. … Step 7: Conclusion Report.

What are the 2 types of stability?

Two Types Of Stability Stability is the ability of an aircraft to correct for conditions that act on it, like turbulence or flight control inputs. For aircraft, there are two general types of stability: static and dynamic. Most aircraft are built with stability in mind, but that’s not always the case.

How suspension improves the stability of drugs?

There are some useful methods to improve the physical stability of a suspension, such as decreasing the salt concentration, addition of additives to regulate the osmolarity, as well as changes in excipient concentrations, unit operations in the process, origin and synthesis of the drug substance, polymorphic behavior …