Overview of Container Closure Systems for Packaging Human Pharmaceuticals and Biological Products

 Containers for biological product packaging are made of materials that are used to produce packaging components [eg, COP, glass, high-density ethylene (HDPE), metal.

5ml COP vial

100ml COP injection vial

Package refers to any component of the container closure system, including containers (such as ampoules, vials, bottles), container linings (such as tubes), sealing sheets (such as screw caps, chambers), rubber stoppers, etc. Top seal, container inner seal, infusion port [for example, large volume injection (LVP) outer packaging drug delivery accessories and container labels Primary packaging components refer to the packaging components that may be in direct contact with the agent, secondary packaging components Refers to packaging components that do not come into direct contact with the drug product.

RTU(ready to use) 2ml COP vial

The container closure system refers to the sum of all packaging components that contain and protect the preparation. If the secondary packaging component is equipped with the function of providing additional protection for the product, the container closure system includes the primary packaging component and the secondary packaging components. Packaging systems are equivalent to container closure systems. Packaging or marketing packaging refers to container closure systems and labels, associated accessories (e.g., measuring cups, droppers, ER medications) and outer packaging (e.g., carton or shrink wrap). Marketing packaging refers to packaging provided to pharmacists or retail and consumer The packaging of the buyer, excluding packaging specially used for transportation.

Disposable Intranasal Atomization Device

Quality refers to the physical, chemical, biological, biological, bioavailability, and stability attributes of a drug that are considered therapeutic or diagnostic. In this guideline, this term can also be understood as characteristics such as safety, identification, specification, quality and purity. Extractables full refers to the analytical characteristics of substances extracted from packaging components "usually using color language method". Extractables quantitative profile means that each detected component can be quantified.

FDA approves first treatment for Friedreich's ataxia

 Action

FDA has approved Skyclarys (omaveloxolone) as the first treatment for Friedreich's ataxia, a rare, inherited, degenerative disease that damages the nervous system, characterized by impaired coordination and walking.

Patients take Skyclarys capsules orally without food once a day at a recommended dosage of 150 mg.

Disease or Condition

Friedreich's ataxia causes progressive damage to the spinal cord, peripheral nerves, and the brain, resulting in uncoordinated muscle movement, poor balance, difficulty walking, changes in speech and swallowing, and a shortened lifespan. The condition can also cause heart disease. This disease tends to develop in children and teenagers and gradually worsens over time.

Although rare, Friedreich's ataxia is the most common form of hereditary ataxia in the United States, affecting about one in every 50,000 people.

Effectiveness

The efficacy and safety of Skyclarys to treat Friedreich's ataxia was evaluated in a 48-week randomized, placebo-controlled, and double-blind study [Study 1 (NCT02255435)] and an open-label extension.

Study 1 enrolled 103 individuals with Friedreich’s ataxia who received placebo (52 individuals) or Skyclarys 150 mg (51 individuals) for 48 weeks. Of the research participants, 53% were male, 97% were white, and the mean age was 24 years at study entry. Nine (18%) patients were younger than age 18.

The primary objective was to evaluate the change in the modified Friedreich's Ataxia Rating Scale (mFARS) score compared to placebo at week 48. The mFARS is a clinical assessment that measures disease progression, namely swallowing and speech (bulbar), upper limb coordination, lower limb coordination, and upright stability. Individuals receiving Skyclarys performed better on the mFARS than people receiving placebo.

In a post hoc analysis, individuals who continued treatment with Skyclarys in an open-label extension for up to three years performed better on the mFARS compared to a matched set of untreated patients from a natural history study.

Safety Information

The most common side effects of Skyclarys were an increase in alanine transaminase and an increase of aspartate aminotransferase, which can be signs of liver damage, headache, nausea, abdominal pain, fatigue, diarrhea and musculoskeletal pain.

See full prescribing information for additional information on risks associated with Skyclarys.

45ml plastic medicine bottle with CRC

50ml desiccant bottle

Source from FDA:https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-treatment-friedreichs-ataxia

What are the quality inspection items of COP vial

 COP vial is a packaging container processed from a new type of material, which is mainly used for the storage of proteins, anti-tumor, high pH value and other drugs. The quality of packaging is closely related to the safety and stability of drugs, so what are the quality inspection items for this packaging?

RTU(ready to use) 2ml COP vial

COP vials are widely used in biopharmaceuticals. Compared with ordinary drugs, biopharmaceuticals have stricter requirements on packaging quality. Appearance is the first impression. First of all, the appearance of COP vials should have a uniform transparent color. The surface of the bottle should be smooth and flat, without deformation and obvious scratches. There shall be no trachoma, oil stains, air bubbles, and the mouth of the bottle shall be flat and smooth. Secondly, it also includes visible foreign matter, sterilization test, identification, sealing, absorbance, acidity and alkalinity, total organic carbon, extractable metals, residue on ignition, etc.

5ml COP vial

100ml COP injection vial

In addition, if the precipitate or other toxicity on the packaging material will also affect the safety of the drug. Therefore, the quality inspection items of this packaging also include dissolution tests (solution clarity, color), biological tests (cytotoxicity, skin sensitization, intradermal irritation, acute systemic toxicity, hemolysis).

The above are the quality inspection items of COP packaging materials. These items are indispensable and together constitute the quality system of this packaging, and are also the key to ensuring the final quality of the product and ensuring the stability and safety of the drug within the validity period.

Composition of the calf paste syringe

 Newborn Calf Nutrition Cream is an oral paste that provides energy, colostrum, probiotics, active protein and vitamins to prevent indigestion and help newborn calves get started quickly. This paste is packaged in a pourer, mainly because of its unique functionality, but also because of its structure.

Calf Paste Tube Syringe Applicator 30cc 15cc 60cc

The calf paste tube is composed of a tube sleeve, a push rod, a piston, a protective cap, with a positioning ring or without a positioning ring. After the drug filling is completed, the push rod and the protective cap can achieve a sealing effect. At this time, it plays the role of drug storage. The role of the container. Remove the protective cap and push the push rod, and it instantly turns into a drug delivery tool, which also has the functions of drug storage and drug delivery.

The speciality of this packaging is also reflected in the aspect of dosing. There is a standard scale printed on the push rod. After calculating the appropriate dose, slide the positioning ring to the corresponding scale and push the push rod. When the push rod reaches the Stop pushing at the positioning ring, so as to achieve precise control of the drug dose.

From the composition of the calf paste syringe, we can see that it is a packaging container with diversified functions. Such packaging is of great significance for improving the added value of drugs and enhancing the competitiveness of pharmaceutical companies.

Will Gamma sterilization of COP vials change color

 When choosing pharmaceutical packaging, the compatibility with the drug and the overall quality of the product are important considerations for pharmaceutical companies. For some high value-added drugs, whether the COP vial will change color after Gamma sterilization is also a key issue. one of the factors to consider.

RTU(ready to use) 2ml COP vial

Sterilization is a necessary link for packaging to be put into use. Irradiation sterilization is a commonly used method. It is an effective method to kill microorganisms on most substances by using electromagnetic waves generated by ionizing radiation. The rays used for sterilization include electron beams, X-rays and gamma rays, etc., which can control the growth of microorganisms or kill microorganisms in a specific way. X-rays and γ-rays can oxidize other substances or generate free radicals (OH·H) to act on biomolecules, or directly act on biomolecules, breaking hydrogen bonds, oxidizing double bonds, destroying ring structures or making certain Molecular aggregation and other methods destroy and change the structure of biological macromolecules, thereby inhibiting or killing microorganisms.

5ml COP vial

100ml COP injection vial

COP vial is a kind of high-transparency pharmaceutical packaging, which is mostly used for the packaging of biological drugs, high-end chemical drugs and protein drugs. If the color changes after sterilization, it will affect the overall image of the drug and make the drug greatly discounted. Thanks to the good stability of cyclic olefin polymers, this product will basically not change color when sterilized with a radiation dose of less than 15kgy. There will be a slight greening phenomenon if it is above 20kgy, but it will recover part of it after a week. Guaranteed To ensure overall transparency.

In addition, COP vials also have good chemical stability and can tolerate drugs with a pH value greater than 10; low protein adsorption ensures the accuracy of drugs. These characteristics also make the application range of this packaging more extensive.

FDA approves first treatment for Friedreich's ataxia

 Action

FDA has approved Skyclarys (omaveloxolone) as the first treatment for Friedreich’s ataxia, a rare, inherited, degenerative disease that damages the nervous system, characterized by impaired coordination and walking.

Patients take Skyclarys capsules orally without food once a day at a recommended dosage of 150 mg.

Disease or Condition

Friedreich’s ataxia causes progressive damage to the spinal cord, peripheral nerves, and the brain, resulting in uncoordinated muscle movement, poor balance, difficulty walking, changes in speech and swallowing, and a shortened lifespan. The condition can also cause heart disease. This disease tends to develop in children and teenagers and gradually worsens over time.

Although rare, Friedreich’s ataxia is the most common form of hereditary ataxia in the United States, affecting about one in every 50,000 people.

Effectiveness

The efficacy and safety of Skyclarys to treat Friedreich’s ataxia was evaluated in a 48-week randomized, placebo-controlled, and double-blind study [Study 1 (NCT02255435)] and an open-label extension.

Study 1 enrolled 103 individuals with Friedreich’s ataxia who received placebo (52 individuals) or Skyclarys 150 mg (51 individuals) for 48 weeks. Of the research participants, 53% were male, 97% were white, and the mean age was 24 years at study entry. Nine (18%) patients were younger than age 18.

The primary objective was to evaluate the change in the modified Friedreich’s Ataxia Rating Scale (mFARS) score compared to placebo at week 48. The mFARS is a clinical assessment that measures disease progression, namely swallowing and speech (bulbar), upper limb coordination, lower limb coordination, and upright stability. Individuals receiving Skyclarys performed better on the mFARS than people receiving placebo.

In a post hoc analysis, individuals who continued treatment with Skyclarys in an open-label extension for up to three years performed better on the mFARS compared to a matched set of untreated patients from a natural history study.

Safety Information

The most common side effects of Skyclarys were an increase in alanine transaminase and an increase of aspartate aminotransferase, which can be signs of liver damage, headache, nausea, abdominal pain, fatigue, diarrhea and musculoskeletal pain.

See full prescribing information for additional information on risks associated with Skyclarys.

45ml plastic medicine bottle with CRC

50ml desiccant bottle

Source from FDA:https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-treatment-friedreichs-ataxia

FDA Approves First Oral Treatment for Cats with Diabetes Mellitus

 December 8, 2022

Today the U.S. Food and Drug Administration approved the first oral new animal drug to improve glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin. Bexacat (bexagliflozin tablets) is also the first sodium-glucose cotransporter 2 (SGLT2) inhibitor new animal drug approved by the FDA in any animal species. An SGLT2 inhibitor is not insulin and is not for use in cats with the type of diabetes mellitus that requires insulin treatment. The labeling for Bexacat includes a boxed warning regarding the critical need for appropriate patient selection and the potential for certain severe adverse reactions.

As with people, the cells of a cat’s body need sugar in the form of glucose for energy. Cats with diabetes mellitus cannot properly produce or respond to the hormone insulin, which helps cells use glucose as a source of energy for normal function. Without treatment, cats with diabetes mellitus will have high levels of glucose in their blood and urine. The first symptoms of diabetes mellitus are usually increased thirst and urine output, weight loss, and increased appetite. Diabetes mellitus in cats often requires lifelong therapy.

Cats with diabetes mellitus have been traditionally treated with a combination of insulin therapy and diet. Insulin therapy requires owners to administer insulin injections, usually twice a day, roughly 12 hours apart at the same time each day. Bexagliflozin, the active ingredient in Bexacat, prevents the cat’s kidneys from reabsorbing glucose into the blood, causing excess glucose to be passed out in the urine and resulting in lowered blood glucose. Bexacat is given to cats orally once daily via a flavored tablet. 

Although there are notable safety concerns with the use of Bexacat, they can be mitigated by carefully screening cats before starting the drug, continued diligent monitoring regardless of the duration of or response to treatment, and knowing how to promptly recognize and appropriately treat serious and life-threatening adverse reactions.

The data from two 6-month field studies and an extended use field study demonstrated that Bexacat was over 80 percent effective in improving glycemic control in cats with diabetes mellitus. However, potential patients must be selected carefully and screened to evaluate for kidney, liver and pancreatic disease, as well as ketoacidosis (a high level of a type of acids, known as ketones, in the blood). Bexacat should not be used in cats who have previously been treated with insulin, are receiving insulin treatment, or who have insulin-dependent diabetes mellitus, as serious adverse reactions can occur. Bexacat should not be initiated in cats who are not eating well, dehydrated, or lethargic when diagnosed with diabetes mellitus. 

Cats treated with Bexacat may be at an increased risk of serious adverse reactions, including diabetic ketoacidosis or euglycemic diabetic ketoacidosis, which can be fatal. Cats with diabetic ketoacidosis or euglycemic ketoacidosis should be treated as emergencies, including discontinuation of Bexacat and initiation of insulin therapy. All cats who receive Bexacat should be examined and have blood tests at regular intervals following initiation of treatment. Cats should be carefully monitored for lack of appetite, lethargy, dehydration, and weight loss. Cat owners who note any of these signs should stop Bexacat treatment and immediately take the cat to a veterinarian, who should assess the cat for diabetic ketoacidosis or euglycemic diabetic ketoacidosis.

Clients whose cats receive Bexacat should receive a Client Information Sheet informing them of the potential risks associated with Bexacat treatment, signs to watch for, and what to do if their cat becomes symptomatic. There will also be educational outreach to veterinarians to familiarize them with the appropriate use of the product. The outreach and materials will be available so veterinarians can learn about the product before prescribing its use.

As with all new animal drugs, veterinarians and clients should report any adverse events to the sponsor, which is required to provide those reports to the FDA. Veterinarians and clients may also report directly to the FDA.  

Bexacat oral tablets are administered to cats weighing 6.6 pounds (3.0 kg) or greater once daily, at approximately the same time each day, with or without food and regardless of blood glucose level.  

Bexacat is supplied in 15mg flavored tablets in 30 and 90-count bottles.

Bexacat is sponsored by Increvet Inc., based in Boston, Massachusetts.

100ml PP vaccine vial

250ml PE plastic vaccine bottle

Source from FDA: https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-first-oral-treatment-cats-diabetes-mellitus

Xinfuda Disposable Intranasal Atomization Device Successfully Obtained Medical Device Registration Certificate

 Disposable Intranasal Atomization Device is a special drug delivery device, which consists of a needle, a dose limiter, an atomizing device, and a syringe. It can atomize liquid drugs into particles of different sizes and absorb them through the nasal mucosa Acting on specific parts or the whole body, it has the advantages of being painless and avoiding the first-pass effect, and is suitable for the delivery of various types of drugs such as vaccines and peptides.

Disposable Intranasal Atomization Device

Scope of application

It is used for aerosolizing liquid drugs, and is suitable for clinical aerosol administration in the nasal cavity.

Product advantages

1. Painless administration: Umbrella-shaped spray avoids local pain or inflammation caused by injection, and is more easily accepted by patients.

2. Rapid absorption: micron-sized, evenly distributed drug droplets can be sprayed out through the atomization device, and the absorption effect is good.

3. Self-destruction device: push the push rod to the bottom to achieve the purpose of self-destruction of the device, ensuring the safety of one-time use.

4. Precise drug administration: the dose limiter can realize a single quantitative drug administration (the control dose is 0.1ml±0.05ml).

The nasal spray administration method is very mature abroad, and was approved for use in the United States and the European Union in 2003 and 2012. Globally, hundreds of millions of doses of the nasal spray flu vaccine have been used, and its safety has been verified. In short, nasal administration is a drug delivery method that is easy to use, rapid onset and high bioavailability, both in terms of drug efficacy and patient experience.