Compound pharmacists in compounding pharmacies painstakingly work to maintain the stability of compound medications. Nonetheless, every compounding pharmacy isn’t the same. For the same reason, FDA hasn’t yet approved compound medications. However, patients can purchase compound medications from compounding pharmacies which stick to the standards for compounding based on their needs. Besides, Aurora Compounding is a compounding pharmacy with compound pharmacists who devise compound medications while following PCCA compounding methods. Additionally, the aforementioned compounding pharmacy sticks to the NAPRA guidelines to make sure its compound drugs are safe and effective.
How Does Compounding Pharmacies Determine the Stability of Compound Drugs?
It is important for compound pharmacists to ensure that compound drugs retain the same properties and characteristics with compounding. No authentic compounding pharmacy will want to see changes in its compound drugs with time. Five different types of stability are important for compound drugs, including chemical, physical, microbiological, therapeutic, and toxicological. What these stability mean is mentioned below:
Each active ingredient sustains its chemical integrity and strength.
It means compound medications should maintain their forms, solubility, suspending ability, and particle size.
It means the maintenance of resistance to microbial growth.
It means that the therapeutic effect of the drugs doesn’t change.
Toxicological stability denotes that there is not any significant increase in toxicity.
Nonetheless, the following factors can affect the stability of compound medicines, as per PCCA:
Most compounded dosages require heat during their formation. Those medications include suppositories, troches, lollipops, and rapid dissolve tablets. Mentioned below are normal temperature ranges required to compound various dosage forms:
38 to 55 Centigrade
50 to 65 Centigrade
90 to 160 Centigrade
Rapid Dissolve Tablets:
80 to 110 Centigrade
Some compound medications are also sensitive to light. Mentioned below are some of the compound drugs that can suffer the effects of light:
Tretinoin is sensitive to ultra-violet light.
Methylcobalamin is highly sensitive to light when it is in water.
It changes colours when you expose it to light and water
Some compound drugs can also suffer an impact with oxidation. For example, Hydroquinone has a molecular structure that can likely make it oxidize. Similarly, Epinephrine can turn brown when it oxidizes.
Aspirin as a compound medication can hydrolyze to acetic acid and salicylic acid in the presence of water in a dry environment.
These are the factors that can affect the stability of compound drugs. In addition, there are observing compounds that aid in predicting the stability of compound medications.
How to Predict the Instability of Compound Medications
Certain compounds can help you predict the instability of compound medications. Common signs can aid compound pharmacists who rely on PCCA compounding techniques in determining stability issues. In addition, compound pharmacists should take proper steps to make sure their selection and storage of ingredients prevent the stability issues in the following.
Hard Gelatine Capsules:
Hard gelatin capsules or compound medications in solid dosage forms require storage in low-moisture conditions. These compound drugs require prevention from environmental water. By the same token, they require storage in airtight containers. Further, the appearance of condensation, liquid drops or clumping of these drugs signifies improper conditions. In other words, a change in the consistency or the physical appearance signifies their instability. Compound pharmacists should visually examine hard gelatin capsules to ensure they don’t become soft or stick together prior to dispensing.
Solutions, Elixirs, and Syrups:
The formation of precipitates and evidence of excessive microbial growth are also signs of instability. You can identify excessive microbial growth of these compound medications while looking for dark areas/streaks or a change in odour.
Breaking of an emulsion, which means the separation of an oil phase; not easily dispersed, is also a sign of instability.
Excessive crystal growth in suspensions or a cake solid phase, which you can’t suspend via quick shaking, are signs of instability.
Emulsion breakage, crystal growth, and shrinkage due to water evaporation plus evidence of microbial growth are also signs of instability.
Changes in the consistency, excessive leaking, and the formation of particles are signs of instability in ointments.
Excessive softening, brittleness, and changes in melting point are also signs of instability in suppositories.
These are the things you need to look for to predict instability in compound drugs.
Compound pharmacists diligently work day in day out to devise compound drugs for patients who need them. Nevertheless, every compounding pharmacy isn’t equal. For the same reason, there are good as well as bad compounding pharmacies. However, licensed and reliable compounding pharmacies stick to PCCA compounding techniques to devise safe and effective compound drugs. It also aids them in determining the instability in compound drugs that heat light, oxidation, and hydrolysis are also responsible for. Typically, a change in the consistency and the appearance of compound drugs help compound pharmacists determine the instability in compound medications.