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Diabetic Neuropathy and its Management

About more than a half of population in India suffers from diabetes mellitus nowadays.  Out of which, most of them are grappled with its complications like diabetic retinopathy, diabetic nephropathy and diabetic neuropathy etc. The diabetic neuropathy is the most prevalent and common complication found amongst all.  This complication can range from merely aggravating to disabling or even life-threatening. It can lead to dysfunction or sometimes amputation of the particular body part.  The elevated blood glucose level found to be the major factor responsible for diabetic neuropathy.

There are several mechanisms which lead to diabetic neuropathy. The prolonged condition of hyperglycemia triggers several factors like the polyol pathway, advanced glycation product, polymerase pathway and oxidative stress etc. All these factors lead to the destruction of nerve tissue which further becomes a reason for amputation of the damaged body part.

The symptoms of diabetic neuropathy are:

  • Tingling
  • Buzzing and prickling sensation on the feet
  • Hot and cold sensation
  • Loss of knee reflex
  • Proximal leg weakness
  • Numbness or paraesthesia
  • Sharp pain or cramps
  • Loss of balance and coordination
  • Serious foot problems, such as ulcers, infections, deformities and bone and joint pain

The degree and duration of hyperglycemia is the major risk factor of diabetic neuropathy. Insulin resistance is also associated with the endothelial dysfunction that leads to diabetic neuropathy. Moreover, several other risk factors for diabetic neuropathy are the low level of HDLP, cigarette smoking and hypertension etc.

Metformin is an antidiabetic drug which belongs to subclass biguanide. It is mostly employed in the treatment of type 2 diabetes. This medication is used to decrease hepatic glucose production, to decrease glucose absorption and to increase target cell insulin sensitivity. An increased level of glucose elevates the level of an advanced glycation end product in blood. The advanced glycation end products are harmful compounds that are formed when protein or fat combine with sugar in the bloodstream. These compounds accumulate and damage the nerve tissue, which ultimately leads to neuropathy. It has been found in several studies that metformin is capable to reduce the amount advanced glycation end product.

Diabetes-induced oxidative stress is also one of the major cause of neuropathy. Oxidative stress is defined as the excess formation and insufficient removal of a highly reactive molecule such as reactive oxygen species and reactive nitrogen species. In diabetes, the antioxidant enzyme level is reduced in peripheral nerves due to oxidative stress. The elevated level of reactive oxygen species contributes to nerve damage. Metformin also has proved for scavenging reactive oxygen and hydroxyl species. The in vitro and in vivo studies proved the fact that metformin reduces the oxidative stress as well as increase the superoxide dismutase activity. Superoxide dismutase is an enzyme that alternately catalyzes the dismutation or partitioning of the superoxide (O2−) radical into either ordinary molecular oxygen (O2) or hydrogen peroxide (H2O2).

Hence, Metformin is very much effective in diabetic neuropathy. It lowers the blood glucose level as well as also contributes in the removal of oxidative stress and decrease the level of advanced glycation end products in the blood, which regarded as the prime factors responsible for diabetic neuropathy.  

These days many Pharmaceutical manufacturing companies are promoting metformin and glimepiride combinations to help patients to fight diabetes and its complications.  It is very crucial that third party manufacturing or contract manufacturing of Metformin and its combinations must be of high quality with accurate dissolution profile.  They must meet new quality standards established by the Government.  The critical point of third-party manufacturing of Metformin and Glimiperide combination are as follows :

  1.  Both the drugs should be analysed while dissolution testing.
  2. Bi-layered tablets are the one which matches government analytical recommendations.
  3. Drug content should be uniform.

 

References

https://www.sciencedirect.com/science/article/pii/S0014299999003428

https://www.sciencedirect.com/science/article/pii/S001429991530073X

https://www.sciencedirect.com/science/article/pii/S0168822710005826

https://www.sciencedirect.com/science/article/pii/S0026049503000064

https://www.mayoclinic.org/diseases-conditions/diabetic-neuropathy/symptoms-causes/syc-20371580

https://www.webmd.com/diabetes/diabetes-neuropathy#1

https://www.healthline.com/health/metformin-oral-tablet

 

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METHYLCOBALAMIN STIMULATES SEROTONIN CREATION

We all are aware of the fact that, how vitamins are essential for our body. Different vitamins regulate different functions in our body and protect the body from several deficiencies and diseases.  Methylcobalamin is one of them. It is also called as Vitamin B12 and used as dietary supplement. A low level of vitamin B12 makes you feel tired, weak,  slow thinking,  nerve damage, digestive issues and other neurological problems like depression and memory loss. Therefore, many people turn to vitamin B12 supplements to help meet their needs and prevent a deficiency. There are two forms of vitamin B12, Methylcobalamin and cyanocobalamin. Methylcobalamin is the natural form of Vit B12 and cyanocobalamin is manmade. While methylcobalamin contains a methyl group, cyanocobalamin contains a cyanide molecule.

Methylcobalamin is the activated form of vitamin B12 and is being used to treat some nutritional diseases and other diseases in the clinic, such as Alzheimer’s disease and rheumatoid arthritis. Methylcobalamin also promotes the release and formation of several hormones, Serotonin is one of them. Serotonin is one of the essential hormones of the body, produced by nerve cells. Serotonin impacts every part of our body, from emotions to motor skills. Serotonin is considered a natural mood stabilizer. It’s the chemical that helps with sleeping, eating, and digesting. Serotonin also helps in reducing depression, regulate anxiety, heal wounds maintain bone health.

Methylcobalamin has specific biomedical influences in the human body. The body needs B12 to convert homocysteine to methionine, protect DNA and RNA, support energy, protect nerve and brain cells, stimulate serotonin production. Vitamin B12 can only naturally be found in animal products like fish, meat, eggs, milk, etc. Methylcobalamin is the only form of B12 that can cross the blood-brain barrier without help or conversion. Its methyl group stimulates serotonin creation, a neurotransmitter responsible for mood support. It also works directly on brain cells to protect against damage.

There are some other benefits of methylcobalamin like the formation of red blood cells and prevent from anaemia. Methylcobalamin also plays a key role in the pregnancy. The deficiency of vitamin B12 during pregnancy may increase the risk of birth defects, such as neural tube defects. Methylcobalamin is important for the prevention of brain and spinal cord birth defects. An Adequate level of methylcobalamin decreases homocysteine levels in the blood. This may help prevent the development of age-related macular degeneration. Vitamin B12 is involved in energy production in our body. Thus, methylcobalamin is an essential vitamin that contributes in almost all the body functions in our body.

 

https://www.patientslikeme.com/treatment/vitamin-b12-methylcobalamin

https://www.everydayhealth.com/drugs/vitamin-b-12

https://www.practo.com/medicine-info/methylcobalamin-179-apivv

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4772032/

https://www.ncbi.nlm.nih.gov/books/NBK28242/

http://www.jhrr.org/article.asp?issn=2394-2010;year=2014;volume=1;issue=1;spage=5;epage=9;aulast=Mahmood

 

 

 

 

 

 

 

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Is aceclofenac and Paracetamol safe in Pregnancy ?

Pregnancy is regarded as the most delicate period for every woman. The physicians are very careful at this stage for prescribing the medicine to a pregnant lady as during pregnancy health of both mother and child are at stake. There are plenty of drugs prohibited during the pregnancy.

Whenever we suffer from fever and pain, we mostly use the combination of Aceclofenac and paracetamol. The trend of combining drugs is merely used to increase the efficacy of salts and provide the maximum benefits to the patients.  So, let us know about both of the drugs

Aceclofenac

Aceclofenac belongs to NSAIDs (Nonsteroidal anti-inflammatory drugs). NSAIDs are being widely used all over the world for anti-inflammatory, analgesic and antipyretic activities. Aceclofenac is a new NSAID which belongs to a phenylacetic acid group. It is also a prodrug of Diclofenac sodium. Aceclofenac inhibits COX (Cyclo-oxygenase) enzyme which is responsible for the production of prostaglandins. The Prostaglandins are inflammatory mediators which cause pain, inflammation, redness, and fever. Aceclofenac is given orally in the form of a tablet as well as in suspension form. Aceclofenac is also reported to be effective in other painful conditions such as dental pain, rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.

Paracetamol

Paracetamol also belong to NSAIDs (Nonsteroidal anti-inflammatory drugs).

Paracetamol is the most common drug used in fever and pain. Paracetamol is often recommended as the first line treatment for pain, as it is safe for most the people to take and with very fewer side effects. It can be taken as tablets, capsules, liquids, soluble tablets, suppositories, and injection. It also is known as acetaminophen. Paracetamol is a weak inhibitor of prostaglandins. But does not selectively inhibit the COX-2, due which inflammation is not suppressed by paracetamol. Its antipyretic effect makes paracetamol more prominent for the treatment of fever.  Paracetamol lowers the fever by direct action on the thermoregulatory centre in the Hypothalamus and blocks the effects of endogenous pyrogen.

Is Aceclo-para is safe in Pregnancy?

Though the safety profile of Aceclofenac and Paracetamol during pregnancy is not clear, it is suggested to be unsafe for Pregnancy. As Aceclofenac belongs to NSAIDs, these drugs can cause a rare form of fetal anomalies. NSAIDs can cause fetal cardiovascular changes, including the closure of the ductus arteriosus and persistent pulmonary hypertension in the newborn. These drugs are contraindicated in the third trimester of pregnancy. Moreover, it also delays the onset of labour with an increased risk of excessive bleeding in the mother as well as the fetus. Paracetamol can also increase the risk of attention-deficit and hyperactivity disorder (ADHD) when used during pregnancy. The frequencies of fetal abnormalities caused by NSAIDs in human are low. So, women taking Aceclo-para combination in Pregnancy must consult the gynaecologist before using it.

 

https://www.medicineindia.org/pharmacology-for-generic/177/aceclofenac-paracetamol

https://www.webmd.com/drugs/2/drug-57595/paracetamol-oral/details

https://cashkaro.com/blog/how-to-take-aceclofenac-paracetamol-uses-dosage-side-effects-and-more/25027

https://www.ncbi.nlm.nih.gov/pubmed/15662292

https://www.tabletwise.com/questions/is-aceclofenac-paracetamol-safe-in-pregnancy-5101791028969472

https://www.medizzine.com/en/pregnancy/risk.php?name=Aceclofenac

https://www.ahajournals.org/doi/abs/10.1161/01.STR.32.7.1607

https://journals.sagepub.com/doi/abs/10.1111/ijs.12053

https://europepmc.org/abstract/med/8971314

https://europepmc.org/abstract/med/2663407

https://europepmc.org/abstract/med/8823693

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5335881/

https://journals.lww.com/anesthesia-analgesia/Fulltext/2010/04000/Combining_Paracetamol__Acetaminophen__with.30.aspx
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Therapeutic effectiveness of Cefixime

Therapeutic effectiveness of Cefixime

We all are familiar with Antibiotics, their effectiveness in several bacterial infections. These antibiotics are classified as broad spectrum and narrow spectrum. Various classes and subclasses of antibiotics are effective against different types of bacteria. Cefixime is one of the majorly used antibiotics in numerous bacterial infections. It comes under the class of broad-spectrum antibiotics, which means it is effective against a wide variety of different types of bacteria. Cefixime is the third generation cephalosporin antibiotic. Cefixime was approved for medical use in the United States in 1989. It is on the World Health Organization’s List of Essential Medicines, the most effective and safe medicines needed in a health system.

How Cefixime kills the bacteria?

Antibiotics are also classified as bactericidal and bacteriostatic. Cefixime comes under bactericidal antibiotic. It works by interfering with the formation of the bacterial cell wall. Cefixime binds to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall. Moreover, it inhibits transpeptidase which prevents cross-linking of the bacterial cell wall. Inhibition in the cell wall formation leads to the death of bacteria.

Cefixime is much stable in the presence of β-lactamase enzymes hence many organisms resistant to penicillin’s and some cephalosporins may be susceptible to Cefixime. It is highly active against gram-negative cocci, gram-negative bacilli and anaerobes than gram-positive cocci and bacilli. It is not active against pseudomonas

Cefixime is effective against:

Gram-positive

  • Streptococcus pneumoniae
  • Streptococcus pyogenes

Gram-negative Organisms

  • E.coli
  • H. influenzae
  • Moraxella catarrhalis
  • Proteus mirabilis
  • N. gonorrhea

Cefixime is used in the various infections

  • Tonsillitis
  • Pharyngitis
  • Otitis media
  • Bronchitis
  • Urinary tract infections
  • Gonorrhea

Cefixime has been studied in numerous clinical trials for different bacterial infections.  Cefixime found effective in these clinical trials. It has been found in a clinical study that was held in Japan that complicated urinary tract infection treated with a daily divided dose of Cefixime 200mg or a single dose of 400mg.

It has been found in the multicenter trial in Germany that Cefixime at a dose of 400mg orally for 5-10 days gives a significant improvement of the patients suffering from acute bronchitis. As compared to amoxicillin, the improvement rate of patients of respiratory infections who were treated with 400mg Cefixime is much larger than amoxicillin.

In comparison with penicillin, Cefixime is more effective in the treatment of Pharyngitis. An open-label randomized trial was conducted to compare the efficacy and safety of Cefixime, 8 mg/kg once daily and penicillin V, 250 mg 3 times daily. At the end of the therapy, the bacteriologic eradication rate of Cefixime was 97% and in case of Penicillin, it was 77% which shows that Cefixime is much effective than penicillin in Pharyngitis.

Even a single dose of 400 mg of Cefixime at once provides a remarkable improvement in Gonorrhea. It has also noted that Cefixime also effective in otitis media at a dose of 8mg/kg/day when it has been given to the children at the age of 6-12 years old for 10-14 days.

Typhoid fever is most common in developing countries. Various clinical trials are conducted on the efficacy of Cefixime in typhoid fever. An open-labelled, non-comparative, study was conducted in 112 subjects to evaluate the efficacy and safety of Cefixime on typhoid fever in multiple hospitals of Nepal. A dose of 200mg of Cefixime was given twice to the patients for 7 days. A significant reduction was seen in patients at the end of the study. This study proves that Cefixime is safe and efficacious for the treatment of typhoid fever.

Cefixime is regarded as a safe drug. It can also prescribe to pregnant as well as breastfeeding women. Any carcinogenic and mutagenic activity doesn’t report yet in the various animal as well as in vitro studies.

 

References

 

https://europepmc.org/abstract/med/1454432

https://link.springer.com/article/10.1007/BF01742990

https://aac.asm.org/content/45/9/2450.short

https://link.springer.com/article/10.2165/00003495-199549060-00010

https://www.tandfonline.com/doi/abs/10.1080/1120009X.1989.11738903

https://www.amjmed.com/article/0002-9343(88)90457-3/fulltext

https://www.amjmed.com/article/0002-9343(88)90457-3/fulltext

 

 

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Pharma Third Party Manufacturing and Loan license

Pharma Third Party Manufacturing and Loan license

Loan license

A loan license means a license which a licensing authority may issue to an applicant who does not have his own arrangements for manufacture but who intends to avail himself of the manufacturing facilities owned by a licensee in form 25 or in form 28 as the case may be.

Third Party Manufacturing

Under Third Party Manufacturing arrangement the firm/unit (A), enters into an agreement with the manufacturing company (B), where B agrees to manufacture generic/patent-proprietary products of A in its manufacturing facility at agreed terms.

Firm ‘A’ purchases such manufactured products from ‘B’ on the basis of wholesale drug licence. ‘B’ obtains the permission of those products in its license, if not already licensed.

http://cdsco.nic.in/forms/list.aspx?lid=1834&Id=8

http://www.pharmoutsourcing.com/Featured-Articles/166240-Third-Party-Manufacturing-From-Concept-to-Contract/

 

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BENEFITS OF GINSENG MULTIVITAMIN & MULTIMINERAL CAPSULE

BENEFITS OF GINSENG MULTIVITAMIN & MULTIMINERAL CAPSULE

Ginseng Multivitamin & Multimineral capsule is a food supplement known to have multiple beneficial effects on the human body. These multiple effects are due to its stable composition which contains three different categories of components i.e.

Ginseng herb Multivitamins *        Vitamin A (acetate)*        Nicotinamide*        Vitamin B1

*        Vitamin B2

*        Vitamin B6

*        Folic acid (Vitamin B9)

*        Vitamin C

*        Vitamin D3

*        Calcium D Pantothenate

 Multiminerals *        Calcium*        Phosphorus*        Ferrous fumarate

*        Zinc

*        Magnesium

*        Potassium (Potassium sulfate)

*        Manganese (Manganese sulfate)

*        Copper (Copper sulfate)

*        Iodine (Potassium iodide)

 

These three components cover the daily requirement of the human body. These requirements are completed due to the following benefits of this composition:

  • GINSENG

Its genus name “Panax” tells all about ginseng which means “all healing”. It was initially used as a muscle relaxant in Chinese medicine. Besides, its consumption also improves aphrodisiac activity (increases libido), helps to manage erectile dysfunction and boosts the immune system.

  • MULTIVITAMINS
  • Vitamin A: Beneficial for good vision, especially night vision

Helps in the growth & repair of skin

Formation & maintenance of teeth, bones, soft tissues & white blood cells

  • Nicotinamide: Helps in energy production & nutrient synthesis

 Play a role in preventing type 1 diabetes & some cancers

 Regulation of cell differentiation & cell death

  • Vitamin B: Helps the body to produce energy

Helps to form red blood cells

Healthy functioning of muscles, nerves & heart

Immune booster

Mood Lifter

Help cells to synthesize and maintain DNA

Prevents kidney disease in patients with diabetes

  • Folic acid: Helps to produce & maintain new cells

Prevents changes in DNA due to cancer

Reduces the risk of neural tube birth defects while pregnancy

  • Vitamin C: Helps to treat & prevent scurvy

Boosts the immune system

Helps to lower hypertension

Helps to treat lead toxicity

Helps to combat strokes

Helps to make blood vessels & body muscles strong

Helps to repair wounds

  • Vitamin D3: Supports the health of the immune system, brain & nervous system

Important for regulation of calcium & phosphorus regulation

Helps in the maintenance of healthy bones & teeth

Protective effect against cancer, type 1 diabetes and multiple sclerosis

  • Calcium D Pantothenate: Helps to carry out nervous system functions

Helps to treat acne

Helps to treat morning stiffness

Helps to treat rheumatoid arthritis

Helps to synthesize red blood cells & hormones inside the body

Reduce the healing time of wounds

Helps to reduce triglycerides & LDL cholesterol inside the body and raises HDL cholesterol levels

  • MULTI MINERALS
  • Calcium: Important for bone health

Helps in the functioning of heart, muscles & nerves

  • Phosphorus: Helps in healthy bone formation

Helps to improve digestion

Helps to regulate excretion and proper nutrient utilization

Remove minor health problems like muscle weakness, numbness, fatigue and similar ailments

The important element for the cells of the brain

Helps in cell repair mechanism

  • Ferrous fumarate: Treat iron deficiency anaemia
  • Zinc:             Proper functioning of immune & digestive system

Helps to control diabetes

Reduces stress levels

Helps in energy metabolism

Increase the rate of healing of acne & wound

Helpful in hair care, weight loss & eye health

Play a vital role in protein synthesis

Helps in building strong muscles

  • Magnesium: Helps to build strong bones

Enables the nerves to function

Essential for the production of energy from food

Helps to treat headaches, asthma and sleeping disorders

Helps to reduce the risk of heart disease and diabetes

  • Potassium (Potassium sulfate): Helps to relieve from stroke, blood pressure, heart & kidney disorders

Help to enhance muscle strength

The primary function in regulating fluid balance & controlling electrical activity of heart & other muscles

  • Manganese (Manganese Sulfate): Involved in bone formation & thyroid function

Helps in calcium absorption

Helps in blood sugar regulation

Helps to improve immune function

  • Copper (Copper sulfate): Helps to synthesize red blood cells

Acts as a component in nerve fibres & collagen

Required in the body to produce antioxidants

Essential for proper growth

Has anti-carcinogenic activity

Helps in the production of melanin in the body

Helpful for the health of hairs & skin

  • Iodine (Potassium iodide): Required for healthy function of the thyroid gland

Helps to prevent arthritis

Helps to tackle emotional disorders

Stimulates salivary glands for treating coughs

Reduces the occurrence of growth and development problems

OVERALL BENEFITS

  • Helpful in energy production inside the body
  • Helpful in boosting the immune system
  • Reduce the risk of developing advanced age-related macular degeneration
  • Protective against the risk of development of cancer, diabetes and high blood pressure
  • Beneficial for healthy teeth, bones, muscles, soft tissues & nerve cells
  • Helpful in proper digestion, muscle response, hormone production, manufacture of antibodies and communication in the nervous system

 

REFERENCES

 

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WHO Good Manufacturing Practices (WHO-GMP) for Pharmaceutical products: Key Points

WHO Good Manufacturing Practices (WHO-GMP) for Pharmaceutical products: Key Points

CGMPs  provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.

  • Design of the Facility-Uniflow
  • Validation of The Process
  • Good Documentation Practices -Write good procedures and follow them (SOPS & STPS)
  • Define Roles & Responsibilities -Identify who does what.
  • Good Record Keeping (Archiving)
  • Practice good hygiene
  • Training & development of the staff at regular intervals
  • Perform regular audits (Internal audits, vendor audits etc)

 

http://www.who.int/medicines/areas/quality_safety/quality_assurance/TRS986annex2.pdf

http://www.who.int/medicines/areas/quality_safety/quality_assurance/gmp/en/

http://www.who.int/medicines/areas/quality_safety/quality_assurance/QualityAssurancePharmVol2.pdf

http://www.cdsco.nic.in/writereaddata/GMP%20Checklist.pdf

http://www.cdsco.nic.in/writereaddata/ScheduleM(GMP)6.pdf

 

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Importance of Quality Packing Material in Third Party Pharmaceuticals Manufacturing

Medicine plays a crucial role in maintaining health, preventing disease and saving lives. However, ineffective medicines pose great risks to individuals and even threaten lives.

Ineffectiveness takes several forms, such as medicines containing less than the stated dose of the active ingredient or containing unstated or harmful substance(s). Similarly, fake or counterfeit medicines and medicines that have been degraded or adulterated due to improper storage and handling may also be ineffective.

These days as more and more companies are opting for THIRD PARTY MANUFACTURING, so it becomes all the more critical for marketing companies to keep a check on the quality of packaging material, like foil, carton used by the manufacturer. Small but very crucial precautions at the time of manufacturing can help in maintaining the quality of the finished product till its actual expiry date. Ultimately it helps in fighting the diseases.

Critical Example

Amoxicillin and clavulanic acid is a broad-spectrum antibiotic useful for the treatment of the number of bacterial infections. It is a combination antibiotic consisting of amoxicillin trihydrate, a β-lactam antibiotic, and potassium clavulanate, a β-lactamase inhibitor. This combination restored efficacy against amoxicillin-resistant bacteria that produce β-lactamase.

Clavulanic acid is volatile and unstable when exposed to high temperatures and high pH . In addition, clavulanic acid is hygroscopic; therefore, 30% RH or less is desirable for storage. The poor quality packaging material can cause deterioration of clavulanic acid in amoxicillin-clavulanic acid combination thus reducing its effectiveness.

 Importance of packaging

Packaging is referred to as the collection of different components which surround the pharmaceutical product from the time of production until its use.

 Packaging material

  •  Protect against all adverse external influences that can change the characteristics of the product.
  • Protect against microbial contamination.
  • Protect against physical damage.
  • Carry the correct information and identification of the product.
  • Tamper evident / Child resistance/ Anti counterfeiting.

Selection of packaging material

  • Moisture barrier requirements
  • Light barrier requirements
  • Gas barrier requirements
  • Chemical properties

 Testing and stability

Critical parameters during the screening of PM.

It should not release chemicals

  • It should not release visible and /or sub-visible particles
  • It should not Adsorb or absorb pharmaceutical components
  • It should not chemically reactive to the pharmaceutical product
  • It should not degrade on coming in contact with pharmaceutical products

Use of quality of packing material may have a non-significant impact on the cost of third-party manufacturing pharma products, but the use of POOR QUALITY packaging material puts each and every stakeholder in the chain at RISK specifically the end user The Patients.

 

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Third Party Manufacturing of Iron Tablets: Critical Points

Iron is a crucial supplement and has huge consumption. The iron formulation is sensitive to light and moisture and improper manufacturing or storage conditions deteriorate it very fast. Third party manufacturing of Iron pills/Tablets/capsules is very critical and must be done very very carefully.

As we talk about the third party manufacturing of iron pills, sometimes while having the iron pill it may wonder you how these pills are manufactured. What mechanism, what procedure, what ingredients and how much quantity and which instruments would behind the manufacturing of such a beautiful embossed tablet. Nowadays, there are different kinds of tablets available in the market, different colour, shape and printing on it. As the iron tablets seem to be beautiful and polished but there are certain problems come during the manufacturing of the particular iron tablet.

Moisture: Moisture content in the environment or we can say that the humidity plays a major role in the tablet manufacturing. For iron pills, the manufacturing scenario and the storage have an optimized level of humidity. The iron pills are very sensitive to humidity. It can influence the physicochemical properties of iron pills like hardness, disintegration time and dissolution rate. These changes may alter bioavailability, and therapeutic efficacy, even though the drug potency.

Temperature: Together with humidity, temperature also influences the manufacturing process of the iron pills. An experiment was conducted by the scientists to determine the influence of temperature and moisture content on the potency of the iron tablet which gives evidence of the effect of temperature and moister on the iron tablet, which converts ferrous to ferric form in the tablet that is not soluble and not absorbed by the gastrointestinal tract. This causes the loss in desired treatment or less effect to desired treatment.

Picking: Just like the normal tablet, the iron tablet also encounters picking problem during the manufacturing problem. Inaccurate addition of the excipients is the major cause of picking. During the manufacturing process, the upper portion of the tablet gets sticks to the punch surface and gets eroded from the tablet surface. Various factors are responsible for it like rough punch surface, the Sticky surface of the tablet; hot granules while compression and excess moisture. This problem is minimized by the proper drying of granules, reduce the amount of or change the binder so that the adhesive force is decreased more cohesive it becomes.

Capping: There is a complete or partial separation of upper and lower surface of the tablet horizontally. This hurdle arises due to entrapment of air in the tablet material and tablets get separated out in two layers. Large no. of fines in the material, too much-dried granules, inadequate binder and improper compression are the major reasons for this problem. By the addition of the proper amount of binder, by removing fines from granules and by proper compression it can be minimized.

Mottling: coloured pills seem to be very nicely polished. But, many problems occur during the colouration of the tablets. Mottling is one of the problems arises during colouration. It is the uneven distribution of the colour on the surface of the tablet, with dark and light patches on it. Degradation of the excipients with the different colour is the major reason mottling. Improper mixing of the coloured excipients is another reason for the mottling. The proper addition of coloured binder and proper mixing of excipients leads to the removal of mottling.

Tablet is the novel dosage form having the greatest dose precision and least content and has the lowest cost of all oral dosage form. The iron in the tablet form is most suitable. We can add other nutrients with the iron in one dosage form. For Third Party Manufacturing of Iron tablets it crucial to look for quality systems and technical know-how as it can have the long-term impact on patient health and companies reputation. 

 

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Irrational Fixed dose combinations: Awareness must for Pharmaceutical manufacturers & marketing companies

Irrational Fixed-dose combinations: Awareness must for Pharmaceutical manufacturers & marketing companies

Combination products, also known as fixed-dose drug combinations (FDCs), are combinations of two or more active drugs in a single dosage form. Fixed ratio combination products are acceptable only when the dosage of each ingredient meets the requirement of a defined population group and when the combination has a proven advantage over single compounds administered separately in therapeutic effect, safety or compliance

The rationality of FDCs should be based on certain aspects such as

  • The drugs in the combination should act by different mechanisms.
  • The pharmacokinetics must not be widely different.
  • The combination should not have the supra-additive toxicity of the ingredients

Some irrational fixed-dose drug combinations available

Norfloxacin + Metronidazole; Norfloxacin + Tinidazole; Norfloxacin + Tinidazole + Loperamide; Norfloxacin + Tinidazole + Dicyclomine

Irrationality

Though claimed to be broad spectrum, combining (antiamoebic) with a fluoroquinolone (antibacterial) is irrational because patient suffers only from one type of diarrhoea. Using this combination adds to cost, adverse effects and may encourage resistance.

Nimesulide + Diclofenac; Nimesulide + Dicyclomine + Simethicone; Nimesulide + Paracetamol; Nimesulide + Cetirizine + Pseudoephedrine; Nimesulide + Paracetamol + Tizanidine

Irrationality

Combining two NSAIDs may increase the side effects of both the NSAIDs. There is little documentary evidence that a preparation containing more than one analgesic is more effective than a single ingredient preparation.

Cisapride + Omeprazole; Mosapride + Pantoprazole ; Ondansetron + Pantoprazole

Irrationality

In patients with gastroesophageal reflux disease, the use of this combination has shown no benefit due to the addition of prokinetic drugs.

In the last few years, pharma marketing business & number of companies has grown manifold, so many of the companies are opting for third-party manufacturing of their product. The tendency is to bring new formulations specifically fixed-dose combinations without making much effort on research & development of such formulations. It is utmost important to aware all the stakeholders about the merits and demerits of fixed-dose combinations.  Regulatory knowledge of various studies required to establish safety and efficacy of these combinations and strict compliance to such regulation is must for all the stakeholders.

Notification of banned compositions 10-March 2016

http://www.cdsco.nic.in/writereaddata/SO%20705(E)%20TO%201048(E)%20DATED%2010-03-2016.pdf

http://www.jpharmacol.com/article.asp?issn=0976-500X;year=2011;volume=2;issue=1;spage=45;epage=48;aulast=Jadav

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3117572/

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2432494/

http://medind.nic.in/ibi/t06/i3/ibit06i3p169.pdf

 

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