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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.

Dangers involved when you take excessive high potency supplements

High potency vitamin and mineral supplements are of great benefit to your body. They help your

body cells function normally and also assist in fighting and preventing diseases. However, just like

anything else, you don’t need to abuse high potency supplements as it can be very dangerous. Always

use them as prescribed.

When you take higher than recommended doses of some vitamins you may cause severe problems.

For example vitamins D, A, E and K are fat soluble and this means that they are stored in the body.

Lot of doses of these can be harmful to the body.

Most of the water soluble vitamins such as the vitamin B6 are also toxic when taken in excess. Huge

intakes on the other hand can hide deficiencies on vitamin B12. In some extreme cases that involve

people taking 100 times the recommended dietary intake can stop the work of anticonvulsant drugs

like those used in epilepsy.

Excessive doses of some high potency minerals can also cause problems. At just five times the

recommended dietary intake, iron, zinc, chromium and selenium can be raised up to toxic levels in the

body for example

 Large doses of fish oil may lead to decreased blood clotting

 High vitamin B6 can cause some type of nerve damage

 High vitamin C doses can cause diarrhoea

 High vitamin A doses can cause birth defects and can also cause problems in the central

nervous system, bone, liver and skin disorders

 Iron toxicity is very common. Very small amounts of over the recommended dietary intake of

iron can cause gastrointestinal upset, black bowel action and nausea. Severe toxicity of iron

can lead to a coma and even death.

 Large fluoride intake can stain the teeth, weaken them. This problem is especially

experienced with children.

Elements of High potency drugs

Potency is a quantity of medicine commotion articulated regarding the quantity needed to create an result

of given strength. Drugs with high potency evoke a certain reaction at low mixture with a drug with low

potency evokes the same response only at higher levels.

Affinity and efficacy

The level of either high potency or low potency depends on the affinity and efficacy. It is the power of

the medicine to combine to a receptor. The second, efficacy is the connection amid receptor tenancy and

the aptitude to start a retort at the cellular, molecular, system level or tissue. In this association, the

response is directly proportional to the effect and it relies on both drug-bound receptor and drug binding

and the response is formed therefore potency is dependent on both efficacy and affinity. The agonist,

ligand drug or hormone which binds to the receptor inaugurates the response is usually cut to A or D.

Under a particular concentration of agonist [A]), E is very little to calculate nevertheless at higher levels

it turn out to be substantial and increases with agonist attentiveness [A] til at adequately high

concentrations it cannot be improved by raising [A] and asymptotes to a maximum.

A maximum possible effect for an agonist is Emax.

The convergence of A at which E is 50% of Emax is referred as the partially maximal effectual mixture

and is shortened [A]50, or most commonly EC50. Therefore the word potency can be explained in short

form as [A]50 value where the lower the [A]50, the less drug concentration is needed to produce 50% of

maximum effect and the higher the potency

However, highpotency does not mean more side effects. The part of the drug molecule that forms the

atoms and groups which bind to the receptor is known as The pharmacophore. The part of the particle

which isn’t occupied in binding except may hinder with binding slightly is the “auxophore.


High Potency Drugs of Active Pharmaceutical Ingredients are surveyed to have a yearly advancement of

14 %. They speak to around 14% of the total pharmaceutical business segment, and this offer is set to rise

unequivocally. Regardless of the way that this creating business part is appealing, it demonstrates a

gigantic test for pharmaceutical makers to overhaul existing workplaces that are set up to handle just non

solid APIs—the test being the noteworthy cost associated with the particular direction anticipated that

would ensure that delegates and their surroundings are protected from presentation. Various assenting

producers are in like manner manufacturing new workplaces that are arranged especially for the amassing

of High Potency Drugs of Active Pharmaceutical Ingredients, which require an endeavor of countless past

regular extraordinary gathering sharpens creation workplaces. This hypothesis may fuse specific

workplaces for High Potency Drugs of Active Pharmaceutical Ingredients–antibody conjugations that join

both capable compound dealing with and biologic get ready capacities.

The importance of a High Potency Drugs of Active Pharmaceutical Ingredients vacillates depending upon

the written work;

• A pharmacological element settling or widely appealing with normal activity at around 150 ug/kg

of body weight or underneath in individuals (accommodating step by step estimation at or

underneath 10 mg)

• A dynamic pharmaceutical settling or center with a word related presentation limit

• A pharmacological element altering or center with high selectivity and with the likelihood to

achieve malady, changes, developmental effects, or regenerative noxious quality at low


• Then repeating, as per normal procedure, a novel compound of dark quality and noxious quality.

Room weight differentials expected for control, with the rule High Potency Drugs of Active

Pharmaceutical Ingredients-dealing with area at negative weight to incorporating rooms, segregated

spaces and vestibules around collecting and research focus spaces to give gowning and deg-owning

regions and genuine weight differentials. Kept access to ensure that solitary the key arranged delegates

enter the High Potency Drugs of Active Pharmaceutical Ingredients-dealing with locales warming,

ventilation, and circulating air through and cooling structures planned for single-pass air—no entry, with

temperature, moisture, and particulate controls.

High-Potency APIs

High-potency assembling of active pharmaceutical ingredients is a developing and

concentrated ability. High-potency active pharmaceutical ingredients (HPAPIs) are a corner

yet developing territory for pharmaceutical producers and contract fabricating associations

(CMOs). Specific contemplations in office outline, gear, operation, and procedure security

are expected to accomplish the coveted level of control of the medication substance or

completed medication item. For medication substance fabricating, the HPAPI might be a little

atom, biologic, or a half breed of the two, for example, an antibody–drug conjugate, which

interfaces a cytotoxic little particle to a monoclonal immune response.

There are an expanding number of organizations creating very high potency active

ingredients since they are attempting to concentrate on unmet restorative needs. So from a

business point of view, organizations will be put under expanding weight to make a choice on

whether to make in-house, utilize a CMO, then again participate in some sort of mixture

organization with a CMO.

Profoundly high potency active pharmaceutical ingredients (HPAPIs) speak to a huge change

in the way pharmaceutical trend-setters are utilizing little atoms to convey new patient

treatments. This shift toward profoundly strong APIs has not just prompted a pipeline of

more successful drugs that require lower dosages and lead to less symptoms, additionally to

new assembling challenges. With 15 years of experience and more than 10 items taken from

early improvement to late advancement then again commercialization, the difficulties that

accompany delivering such high potency APIs, and we anticipate handling them with you.

Together – your inside and out item learning what's more, our improvement and assembling

background, specialized ability, dependable strategies, what's more, front line offices – we

can securely take your exceptionally strong compound to the following level.

The assembling of highly potent medication substances and their medication items requires

specific consideration and consideration in guaranteeing the wellbeing for those included in

the treatment of the materials.