An Example for API manufacturing

There are several types of API manufacturing in present days

Almost every antidote which is biologically synthesized contains Active Pharmaceutical Ingredient in it. There are used in almost every field of pharmacy and especially in herbal treatment. One such example is Gemfibrozil API manufacturing which is a drug used for lowering lipid levels. Lipids are fat layers present under the skin which determines the amount of cholesterol present in our body. People who are obese are prescribed to take this API. It belongs to the drug family of fibrates and this API is manufactured.

This API is an activator of Peroxisome  proliferator-activated receptor – alpha (PPARA) which is a nuclear receptor related directly to the synthesis of carbohydrates and fat. It is proven to be effective in adipose tissue differentiation.

When taken as recommended it results in the reduction of triglyceride levels and very low lipoprotein (VLDL) and a reduction of a less magnitude of LDL levels. It results in the level increase of high-density lipoprotein (HDL) levels. Normal medication dosage of gemfibrozil is 600 mg a short while after breakfast.

Some precautions while taking these drugs are given here. Those who are suffering from kidney failure must not take this.

People with diabetes must also avoid this because intake of these drugs may lead to a rise in insulin levels. This drug may lead to side effects like gallstones, hypokalemia and even cancer also. So these drugs are better to be avoided in case of a longer medication situation.    

Like Gemfibrozil, there are several kinds of API manufacturing like Venlafaxine which is used as an anti-depressant, Carbidopa API manufacturing which is used for the treatment of Parkinson’s disease which affects the key areas of the brain, Diltiazem API which is used for cardiovascular diseases and many more. These make the pharmaceutical industry go leaps and bounds in curing millions of people.   

Stability testing of Active pharmaceutical ingredient

The purpose of stability testing is to deliver indication of how the quality of an Active pharmaceutical ingredient fluctuates with time under the effect of a multiple environmental factors such as temperature, humidity and light

The stability program also contains the study of product-related factors that effects its quality, such as interaction of Active pharmaceutical ingredient with excipients, container closure systems and packaging materials

Test Tube Erlenmeyer Flask Chemistry Laboratory

Various stability testing procedures:

  • Stress testing of the Active pharmaceutical ingredient can assist to recognize the probable breakdown of products, that consequently aids in establishing the degradation pathways and the fundamental stability of compounds and prove the  power of the analytical procedures used for indicating stability.
  • Container closure system :The steadiness studies has to be  done on the Active pharmaceutical ingredient packaged in a container closing system that  triggers the packaging proposed for storage and distribution
  • Specification: The study of stability has to contain testing of those characteristics of the Active pharmaceutical ingredient that are vulnerable to transformation during storage and possibly effect the quality, safety and efficacy. The testing should cover, physical, chemical, biological and microbiological attributes
  • Testing frequency: The frequency of testing should be adequate to establish the stability attribute of the Active pharmaceutical ingredient. For Active pharmaceutical ingredient with an expected repeated test stage or shelf life of at least 12 months,  the regularity of trying long-term storage state must  usually be once in 3 months in the first year, and then every 6 months in the second year and then once a year for the remaining life term
  • Storage conditions: Conventionally an Active pharmaceutical ingredient should be examined under storage conditions that test its heat stability and moisture sensitivity as well. The length of study and the condition in which storage is done is generally enough to cover shipment and storage.