What is the function of the protective cap of the veterinary syringe

 Veterinary syringe is a multi-component special packaging, which is composed of sleeve, push rod, protective cap, positioning ring and other components. These seemingly inconspicuous components play important roles in the storage or delivery of drugs. So do you know the function of the protective cap?

30ml dial a dose syringe

pet syringe

The protective cap is located at the tip of the veterinary syringe. According to different packaging purposes, the size and size of the protective cap will vary, but the function is the same, mainly for sealing. In the state of tightly closing the protective cap, the contact between the external environment and the medicine contained in it can be isolated, and the stability of the medicine can be protected. What we need to pay attention to is that the sealing function of the protective cap needs to be realized together with the push rod, otherwise the complete sealing purpose cannot be achieved.

The above is the function of the plunger of the veterinary syringe. Although it is only a very small component of the package, its function cannot be ignored, and it plays a very important role in the safety and stability of the drug during storage. Xinfuda has been focusing on pharmaceutical packaging for 20 years, and its products have passed the DMF record. Welcome to discuss cooperation.

Design principle of Intranasal Atomization Device

 The emergence of new drugs has led to changes in drug delivery methods. In addition to our common oral drug delivery and injection drug delivery, Intranasal Atomization Device is becoming the choice of many drugs. What is the design principle of the Intranasal Atomization Device as a delivery device for these drugs?

The Intranasal Atomization Device is composed of a syringe, a nasal spray device, a push rod and a dose limiter. After extracting the drug, it converts the liquid drug into mist particles through the nasal spray device, and then acts on specific parts or the whole body through the absorption of the nasal mucosa . This method of administration is rapid, safe, effective and painless, avoiding the risk of needle sticks. The nebulized drug can be directly absorbed into the blood circulation through the nasal mucosa, the preparation time is short, the effect is rapid, and the administration process does not require aseptic operation, which is easier to be accepted by patients.

Disposable Intranasal Atomization Device

Currently, this mode of administration is used for the delivery of various types of drugs such as chemical drugs, liposomes, peptides, and vaccines. Intranasal administration can avoid drug degradation, gastrointestinal irritation, first-pass effect, and achieve brain targeting, etc., and it has attracted increasing attention. Intranasal cell administration for brain disease cell therapy is currently being studied. A new way of cell drug delivery.

Medical device registration certificate

With the rapid development of various technologies, the Intranasal Atomization Device has undoubtedly become a new type of drug delivery method and has been accepted by the public. With the continuous advancement of science and technology, we can look forward to what new drug delivery methods will appear in the future.

COP vial market for antineoplastic drugs

 Antineoplastic drugs refer to drugs that can kill or eliminate malignant tumor cells. Based on the influence of factors such as a huge population base and aging population, the global anti-tumor market demand is gradually released. As a common packaging for antineoplastic drugs, the market demand for COP vials will also be driven.

RTU(ready to use) 2ml COP vial

5ml COP vial

100ml COP injection vial

According to data from Zhongyan Puhua, from 2016 to 2021, the global market size of anti-tumor drugs has increased from US$93.7 billion to US$180.7 billion, and is expected to reach US$304.8 billion in 2025. With the continuous expansion of the market scale, a large number of pharmaceutical companies at home and abroad have strengthened their layout in the field of tumors through various channels. According to Guosheng Securities, more than 1,000 clinical trials conducted by 19 multinational pharmaceutical companies including AbbVie, Amgen, and AstraZeneca, tumors accounted for 45% of the total R&D pipeline. Domestically, Ascentage Pharmaceuticals, Huahai Pharmaceuticals, Roche, and Henlius continued to make new progress in the research and development of cancer drugs.

COP DMF

Generally speaking, antineoplastic drugs are the key areas for the layout of domestic and foreign pharmaceutical companies. Judging from the current research and development progress, the research and development of antineoplastic drugs in my country is in a stage of rapid advancement. At the same time, the packaging for anti-tumor drugs is constantly being updated to provide better safety guarantees for drugs. COP vial is a commonly used packaging for anti-tumor drugs. It has excellent chemical resistance and can tolerate drugs with a pH value greater than 10; it has stable performance in the environment of -196°C—+121°C; good low protein adsorption, these are all Provides a very good security for the drug.

With the continuous emergence of many anti-tumor drugs, the market of COP vials will also be driven, and this packaging will play an important role in the protection of drugs during transportation and storage.

FDA Approves First Over-the-Counter Naloxone Nasal Spray

 March 29, 2023

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Today, the U.S. Food and Drug Administration approved Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription, use – the first naloxone product approved for use without a prescription. Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose. Today’s action paves the way for the life-saving medication to reverse an opioid overdose to be sold directly to consumers in places like drug stores, convenience stores, grocery stores and gas stations, as well as online. 

The timeline for availability and price of this OTC product is determined by the manufacturer. The FDA will work with all stakeholders to help facilitate the continued availability of naloxone nasal spray products during the time needed to implement the Narcan switch from prescription to OTC status, which may take months. Other formulations and dosages of naloxone will remain available by prescription only. 

Drug overdose persists as a major public health issue in the United States, with more than 101,750 reported fatal overdoses occurring in the 12-month period ending in October 2022, primarily driven by synthetic opioids like illicit fentanyl. 

Narcan nasal spray was first approved by the FDA in 2015 as a prescription drug. In accordance with a process to change the status of a drug from prescription to nonprescription, the manufacturer provided data demonstrating that the drug is safe and effective for use as directed in its proposed labeling. The manufacturer also showed that consumers can understand how to use the drug safely and effectively without the supervision of a healthcare professional. The application to approve Narcan nasal spray for OTC use was granted priority review status and was the subject of an advisory committee meeting in February 2023, where committee members voted unanimously to recommend it be approved for marketing without a prescription. 

The approval of OTC Narcan nasal spray will require a change in the labeling for the currently approved 4 mg generic naloxone nasal spray products that rely on Narcan as their reference listed drug product. Manufacturers of these products will be required to submit a supplement to their applications to effectively switch their products to OTC status. The approval may also affect the status of other brand-name naloxone nasal spray products of 4 mg or less, but determinations will be made on a case-by-case basis and the FDA may contact other firms as needed. 

The use of Narcan nasal spray in individuals who are opioid dependent may result in severe opioid withdrawal characterized by body aches, diarrhea, increased heart rate (tachycardia), fever, runny nose, sneezing, goose bumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness and increased blood pressure.

The FDA has taken a series of measures to help facilitate access to naloxone products. In November 2022, the agency announced its preliminary assessment that certain naloxone products, such as the one ultimately approved today, have the potential to be safe and effective for over-the-counter use and encouraged sponsors to submit applications for approval of OTC naloxone products. The agency previously announced in 2019 that it had designed, tested, and validated a model naloxone Drug Facts Label (DFL) with easy-to-understand pictograms on how to use the drug to encourage manufacturers to pursue approval of OTC naloxone products. The model DFL was used to support the approved application along with the results of a simulated use Human Factors validation study designed to assess whether all the components of the product with which a user would interact could be used safely and effectively as intended.

Through the FDA Overdose Prevention Framework, the agency remains focused on responding to all facets of substance use, misuse, substance use disorders, overdose and death in the U.S. The framework’s priorities include: supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing; encouraging harm reduction through innovation and education; advancing development of evidence-based treatments for substance use disorders; and protecting the public from unapproved, diverted or counterfeit drugs presenting overdose risks.
 
The FDA granted the OTC approval of Narcan to Emergent BioSolutions.

Disposable Intranasal Atomization Device

Source from FDA: https://www.fda.gov/news-events/press-announcements/fda-approves-first-over-counter-naloxone-nasal-spray

FDA Approves First Generic Flumethasone for Certain Anti-inflammatory Responsive Diseases in Cats, Dogs and Horses

 April 5, 2023

Today the U.S. Food and Drug Administration approved Bimasone Injectable Solution, the first generic flumethasone, for certain diseases that cause inflammation in horses, dogs, and cats. Bimasone is recommended for the various rheumatic, allergic, dermatologic and other disease states that are known to be responsive to anti-inflammatory drugs (i.e., corticoids) in these species.

Bimasone is a corticosteroid drug. It contains the same active ingredient (flumethasone) in the same concentration and dosage form as the approved brand name drug product, Flucort, which was first approved for use in horses, dogs, and cats on October 21, 1965.  

In horses, Bimasone is approved for use for musculoskeletal conditions due to inflammation, such as bursitis (a painful condition that affects the fluid-filled sacs that cushion the bones, tendons and muscles near a horse’s joints, often in the hip or shoulder), carpitis (inflammation of the connective tissues near the horse’s carpus, which is comparable to the human wrist), osselets (arthritis in the fetlock joint of a horse, often in the front legs), and myositis (rapid muscle wasting, often in the horse’s hindquarters).

In dogs, Bimasone is approved for use for musculoskeletal conditions due to inflammation of muscles or joints, such as arthritis, osteoarthritis, intervertebral disc disease, and myositis. The drug has proven useful in treating canine ear infections (otitis externa) when used with topical medication for similar reasons. It is also approved for certain acute and chronic skin conditions (dermatoses) from various causes to help control the itchy skin (pruritus), irritation, and inflammation associated with these conditions, and for use in treating allergic reactions, such as hives, urticaria (raised itchy rash on skin), and insect bites. Bimasone is also approved for treating shock in dogs, when administered intravenously.

In cats, Bimasone is approved for certain acute and chronic skin conditions (dermatoses) from various causes to help control the itchy skin (pruritus), irritation, and inflammation associated with these conditions.

Bimasone is only available by prescription from a licensed veterinarian because professional veterinary expertise is needed to determine whether Bimasone is an appropriate treatment.

Bimasone is supplied in a 0.5mg/mL concentration in 100 mL multi-dose vials.

Bimasone is sponsored by Bimeda Animal Health Ltd., based in Dublin, Ireland.

100ml PP vaccine vial

250ml PE plastic vaccine bottle

Source from FDA: https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-first-generic-flumethasone-certain-anti-inflammatory-responsive-diseases-cats-dogs-and