Requirements for the moisture content of the desiccant in the effervescent tube

Effervescent tube is a kind of medicine packaging container with excellent moisture-proof performance. On the one hand, its moisture-proof function is realized through strict sealing. On the other hand, silica gel and molecular sieve desiccant are placed inside the package to absorb the internal moisture.

144mm*29mm effervescent tube packaging

For the moisture content of the two desiccants, effervescent tubes also have relevant regulations. In YBB00172004-2015 "Quality Standard for Oral Solid Pharmaceutical Low Density Polyethylene Moisture-Proof Combination Caps", the requirements for the moisture content of the desiccant are as follows:

caps for effervescent tube

In an environment where the relative humidity of silica gel does not exceed 75%, quickly take out the bottle cap from the closed packaging bag, and take out 5-7g of desiccant from the bottle cap, put it in a weighing bottle (W1) with constant weight, and weigh it. Weight (W2), placed in an oven at 180°C ± 10°C (the total time from opening the bottle cap to the time when the desiccant is placed in the oven should not exceed 5 minutes) to constant weight (weighing as W3), calculated by the following formula, containing water The rate must not exceed 4.8%.

Macromolecular sieve In an environment where the relative humidity does not exceed 75%, quickly take out an appropriate amount of the bottle cap from the closed package, take out the desiccant in the bottle cap with tweezers, and place it in a constant weight crucible W0 (add 8-10g to each crucible). ), accurately weighed W1, placed in a high-temperature furnace at 950°C (the total time from opening the cap packaging bag to placing the desiccant in the high-temperature furnace should not exceed 5 minutes), drying for one hour, taking out the crucible, and accurately weighing after cooling. Determine W2, and calculate according to the following formula, and the moisture content should not exceed 4.8%.

The above are the requirements of the effervescent tube for the moisture content of the desiccant. A qualified desiccant is the basis for ensuring its internal moisture-proof performance and is also an important factor to ensure the stability of the effervescent tablet.

Application of COP vial in high pH value drug

 The stability of pharmaceuticals is closely related to the properties of the packaging materials, such as hardness, transparency, dissolution, chemical resistance, etc., which is particularly important for pharmaceuticals in storage. COP vial is a commonly used packaging for high value-added drugs, and its "confidence" also comes from its own good characteristics.

 

5ml COP vial

100ml COP injection vial

Initially, high pH drugs will choose glass as the packaging form, but the main component of glass is silicon dioxide, which is easy to react with glass during drug storage, resulting in glass delamination, which has a significant impact on the safety of drugs, and even Pharmaceutical companies also have to bear high recall costs.

COP is a cyclic olefin polymer. This raw material has very high transparency. The tensile strength and elastic modulus of the material are higher than those of PC, and it has good mechanical properties. In terms of temperature resistance, COP finished products are stable in the environment of -196°C - +121°C. Excellent chemical resistance, can tolerate drugs with a pH value greater than 10, and will not be delaminated when filling alkaline drugs, which plays a crucial role in the safety of drugs. The safety of drugs in special environments such as cells can also be guaranteed. In addition, it also has low protein adsorption and water vapor barrier properties, which can reduce the impact of packaging and external environment on drugs.

COP vial can provide complete safety protection for drugs with high pH, protect the safety and stability of drugs within the validity period, and avoid packaging problems that affect drug effects.

plastic syringe appliaction in calf paste nutritional supplement

 A syringe applicator is both a drug storage container and a delivery tool. Packed as a calf nutritional cream.

Calf Nutritional Cream is a natural nutritional supplement for newborn calves. The gut of a newborn cow is virtually sterile, and supplementing the calf with nutritional cream at birth provides beneficial microbes, vitamins and energy, promoting a healthy appetite and digestive system, allowing the calf to reach its full genetic potential.

Calf Paste Tube Syringe Applicator 30cc 15cc 60cc

As a paste-like preparation, it uses a thick-tipped syringe, which is convenient for calves to take orally. This package is composed of a tube sleeve, a push rod, a piston, a protective cap and a positioning ring. Through the scale on the positioning ring and the push rod, the dosage of the nutrient can be well controlled to better exert its effect.

Syringes tube have the advantages of convenient use and reduced pollution, and are also used in the packaging of drugs such as horse oral pastes, pet nutrition creams, and cockroach medicines.

FDA Approves New Combination Drug for Sedation in Dogs

 March 30, 2022

Today the U.S. Food and Drug Administration approved Zenalpha (medetomidine and vatinoxan hydrochlorides injection) for use as a sedative and analgesic (i.e., pain reliever) to help keep dogs sedated and comfortable while undergoing exams or certain medical procedures.

Medetomidine is a sedative with analgesic properties that has already been approved for use in dogs. Medetomidine can cause a decrease in an animal’s heart rate and can increase the chance of arrythmias (irregular heartbeat), which can be significant in some dogs. This is the first approval of vatinoxan by the FDA. Vatinoxan reduces the negative cardiovascular effects of medetomidine by keeping the heart rate closer to the normal range, thereby improving cardiovascular function and improving the safety profile of medetomidine while the dog is sedated.

Zenalpha is intended to provide sedation along with pain relief that lasts for the duration of the sedation to dogs for clinical examinations or procedures that may require the dog to remain still or quiet. The sponsor conducted a field effectiveness study in dogs that came to the veterinary clinic for non-invasive examinations or procedures that required restraint and sedation. Examples of the examinations or procedures ranged from nail trims to diagnostic procedures to minor surgery to removal of skin masses and draining abscesses. Dogs in the treatment group received one injection of Zenalpha, and dogs in the control group received one injection of an approved veterinary dexmedetomidine injectable solution. Dexmedetomidine is in the same drug class as medetomidine and was used as the control drug because medetomidine was not commercially available when the field study was conducted. 

Dogs that received Zenalpha had less severe decreases in heart rate and body temperature compared to dogs that received dexmedetomidine, and a decrease in the prolonged duration of sedation that can occur with dexmedetomidine alone. Overall, dogs administered Zenalpha had a faster time to onset of sedation and a faster recovery than dogs administered dexmedetomidine.  If necessary, administration of another FDA-approved animal drug called atipamezole can reverse the sedative and analgesic effects of Zenalpha.

Most dogs in both the Zenalpha and control group had no reaction or a mild reaction (slight movement) to intramuscular injection of product. More dogs in the Zenalpha group had a moderate or severe reaction (movement, attention to injection site, vocalization) to the injection of the product compared to the control group. The most common adverse reactions seen in dogs administered Zenalpha were diarrhea, muscle tremors, and colitis (inflammation of the lining of the colon), which occurred in 2 to 3 percent of dogs.

The labeling for Zenalpha includes detailed safety information for people who handle, administer, or are exposed to the drug. The labeling also includes a note to physicians in case a person accidentally gets the drug on their skin or in their eyes, mouth or mucous membranes, or accidentally injects themself. 

Zenalpha is only for use by a licensed veterinarian because professional expertise is required for proper dosing and administration of the product and to monitor the dog’s vital signs while sedated.

Zenalpha is supplied in 10 mL multi-dose glass vials and is sponsored by Vetcare Oy, based in Finland. 

10ml injection vial

30ml dial a dose syringe

Source from FDA

FDA Announces 2022 Public Meeting of the National Antimicrobial Resistance Monitoring System

 July 5, 2022

Today, the U.S. Food and Drug Administration, in cooperation with the U.S. Centers for Disease Control and Prevention (CDC), and the U.S. Department of Agriculture's Food Safety and Inspection Service (USDA-FSIS), its partners in the National Antimicrobial Resistance Monitoring System (NARMS), opened registration for the 2022 Public Meeting of NARMS. The virtual meeting will be held on Wednesday, September 21 and Thursday, September 22, 2022.

During the meeting, representatives from the three public health agencies will discuss progress made toward meeting objectives outlined in the NARMS Strategic Plan: 2021-2025. The agenda for the meeting is available.

The meeting will be preceded by a virtual technical workshop on Tuesday, September 20, 2022, to demonstrate how to access NARMS data online.

The meeting and workshop are free to attend and open to the public. Each session must be registered for separately using the links below. 

Technical workshop (Tuesday, September 20, 2022)
https://fda.zoomgov.com/webinar/register/WN_Eew1FDNHS_ur73BWDgWZrQ

Day 1 of the public meeting (Wednesday, September 21, 2022)
https://fda.zoomgov.com/webinar/register/WN_ErC5aBkjQ8eiVUb2qPZo_g

Day 2 of the public meeting (Thursday, September 22, 2022)
https://fda.zoomgov.com/webinar/register/WN_dOyVe07MTyaGfSFcve11eg

For more information, visit 2022 NARMS Public Meeting registration webpage.

plastic injection vial

animal health paste syringe

Source from FDA

Developing New Drugs FDA

 American consumers benefit from having access to the safest and most advanced pharmaceutical system in the world. The main consumer watchdog in this system is FDA's Center for Drug Evaluation and Research (CDER).

The center's best-known job is to evaluate new drugs before they can be sold. CDER's evaluation not only prevents quackery, but also provides doctors and patients the information they need to use medicines wisely. The center ensures that drugs, both brand-name and generic, work correctly and that their health benefits outweigh their known risks.

Drug companies seeking to sell a drug in the United States must first test it. The company then sends CDER the evidence from these tests to prove the drug is safe and effective for its intended use. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company's data and proposed labeling. If this independent and unbiased review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale. The center doesn't actually test drugs itself, although it does conduct limited research in the areas of drug quality, safety, and effectiveness standards.

Before a drug can be tested in people, the drug company or sponsor performs laboratory and animal tests to discover how the drug works and whether it's likely to be safe and work well in humans. Next, a series of tests in people is begun to determine whether the drug is safe when used to treat a disease and whether it provides a real health benefit.

For more information about the drug development and approval process, see How Drugs Are Developed and Approved.

hdpe pill bottle

effervescent tablet packaging

Source from FDA

FDA Approves the First Generic Firocoxib Tablets for Horses

August 1, 2022

The U.S. Food and Drug Administration has approved the first generic firocoxib tablets for pain and inflammation associated with osteoarthritis in horses. 

Firocoxib Tablets for Horses contain the same active ingredient (firocoxib) in the same concentration and dosage form as the approved brand name drug product, Equioxx Tablets, which was first approved on July 24, 2016.  

Firocoxib is a nonsteroidal anti-inflammatory drug (NSAID). Like many NSAIDs, firocoxib works by affecting certain enzymes that trigger pain, fever, and inflammation. 

Although NSAIDs are effective medications for pain and inflammation, there are potential risks associated with their use. Firocoxib Tablets for Horses, like other veterinary NSAIDs, are only available by prescription because a veterinarian’s expertise is required to determine if Firocoxib Tablets for Horses is an appropriate treatment and to monitor animal health while taking the drug.  

Veterinarians and animal owners should be aware of the potential risks associated with the use of NSAIDs. Serious side effects associated with NSAID therapy in horses can occur with or without warning. The most common side effects associated with firocoxib therapy involve the tongue, lips and skin of the mouth and face (erosions and ulcers of the mucosa and skin) and the kidney. Gastrointestinal, kidney and liver problems have also been reported with other NSAIDs.  

Veterinarians should provide the Firocoxib Tablets for Horses Client Information Sheet with each prescription and refill of the product. 

Firocoxib Tablets for Horses are available as half-scored tablets in 57 mg of firocoxib and are to be administered once daily for up to 14 days. The tablets are supplied in 60-count bottles. 

The New Animal Drug Application for Firocoxib Tablets for Horses is sponsored by Pegasus Laboratories, Inc. based in Pensacola, Florida.

10ml dosing syringe for horse

tablet bottle

Source from FDA

Four Applications of Plastic Animal Health Syringes

 Veterinary packaging is taking on more and more functionality. Syringe is a new type of packaging that not only has the function of drug storage, but also can be used as a drug delivery tool. It is mainly used in the following aspects.

5ml syringe for cow mastitis

Dairy cow mastitis drugs: Dairy cow mastitis is an important disease that endangers the health of dairy cows, and most of its therapeutic drugs use syringes as packaging. The tip of the package is relatively thin, which can be directly administered to the cows, and the operation is convenient.

30ml dial a dose syringe

Horse medicine: mainly ointment for horses, medicine for horse gastroenteritis and other creamy or oily medicines. These medicines are all oral medicines for horses. It can be easily administered through packaging, reducing drug residues.

pet syringe

Pet nutrition cream: This type of medicine is mainly used to supplement the daily nutritional needs of pets. Ordinary packaging can easily be bitten by dogs and cats, resulting in excessive consumption. The syringe is made of polyethylene/polypropylene raw material, and the design of the positioning ring can also control the dosage to ensure the accuracy of the dosage.

cockroach syringe

Cockroach medicine: Cockroaches often appear in some narrow crevices, corners, etc. The slender tip of this syringe can reach various corners and easily complete the application.

The above are four common applications of syringes. It is not only convenient to operate, but also has less residue. Except for the packaging of drugs, some grease products will also choose this packaging form.

Features of 30ml plastic syringe

 Plastic syringe is one of the more prominent functions in veterinary drug packaging. It can not only be used as a drug storage container, but also a drug delivery tool. We take the 30ml specification as an example, it has the following advantages:

30ml dial a dose syringe

1. Easy to use: The 30ml plastic dial a dose syringe is mainly used as the packaging of pet nutrition cream. When in use, open the protective cap and push the push rod to complete the drug administration, which is very convenient to operate. If it is used for uterine perfusion, a special catheter is required.

2. Precise control of drug dosage: This package consists of a tube sleeve, a push rod, a piston, a protective cap, and a positioning ring. A standard scale is printed on the push rod. Calculate the appropriate dosage before administration, and slide the positioning ring to At the corresponding scale, push the push rod, and when the push rod reaches the positioning ring, it will stop, so that the dose of the drug can be precisely controlled, which is conducive to better efficacy of the drug.

To sum up, the 30ml plastic syringe has the characteristics of convenient use and precise control of drug dosage. Of course, according to the different application scope, this kind of packaging also has different specifications such as 5ml, 8ml, 10ml, 15ml, 20ml, 60mland so on.

The innovative design of oral liquid bottle cap

 The cap is an important part of the medicinal plastic bottle, which mainly plays the role of sealing. With the continuous changes in market demand, the functionality of the cap is also more diversified. For example, the oral liquid bottle cap adopts an innovative design on the basis of airtightness, so that it has the function of preventing children from opening, reducing the risk of children ingesting medicines by mistake.

 

28mm child resistant  cap for liquid medicine

Oral liquid is a sterile or semi-sterile oral liquid, which is based on traditional Chinese medicine decoction, extracts the active ingredients in the drug, adds flavoring agents, bacteriostatic agents and other additives, and is processed by filling and sealing injection ampoules. Liquid preparations. The packaging of such drugs is generally dominated by plastic bottles or glass bottles, and the lids are mostly ordinary plastic bottle caps. In order to improve the sealing performance, aluminum foil gaskets are used to seal.

Oral liquid tastes better and is easily accepted by patients, especially children. However, children are in the growth and development period and are full of curiosity about many things. It is easy to mistake the oral liquid for a drink, resulting in accidental ingestion. The press-and-screw oral liquid bottle cap adopts an inner and outer double-layer structure. It cannot be opened only by rotating the cap. It must be rotated while pressing down to open. Such an opening method involves the simultaneous application of force in two different directions, which is difficult for children, which can prevent them from easily opening the package in a short period of time and avoid accidental ingestion of medicines.

Rotational medicine caps are not only used in the packaging of liquid preparations, but are also widely used in solid pharmaceutical plastic bottles such as tablets and capsules. The functionality of the lid is well used.

plastic empty syringe veterinary syringe for animal health disposable dosing syringe manufacturer since 2001-Xinfuda

plastic empty syringe veterinary syringe for animal health disposable dosing syringe manufacturer since 2001-Xinfuda

15ml syringe for pet feeding

30ml dial a dose syringe

60ml syringe for horse