Aptar Pharma Extends its Child-Resistant Nasal Pump Manufacturing Capabilities in North America

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Aptar Pharma, the leading manufacturer of drug delivery systems for nasal applications worldwide, announces the installation of manufacturing capacity for its Child-Resistant and Senior-Friendly Classic Nasal Pump in their Congers, NY site.

Effective April 2017, a new assembly machine for Aptar Pharma’s Child-Resistant (CR) feature for nasal sprays was transferred from Aptar Pharma’s plant in Southern Germany to Congers, NY. This represents an important step in Aptar Pharma’s history, bringing its manufacturing capacity closer to the target market for which this pump has been successfully established.

Aptar Pharma’s Child-Resistant technology platform was developed primarily for the U.S. market when, in 2012, the U.S. Consumer Product Safety Commission (CPSC) issued a rule requiring Child-Resistant packaging for any over-the-counter or drug product containing the equivalent of 0.08 milligrams or more of imidazoline (16 CFR Part 1700.14), a formulation widely used in nasal decongestant topical sprays.

Less than two years after the rule’s announcement, Aptar Pharma introduced its newly-engineered Child-Resistant/Senior-Friendly nasal spray pump to the U.S. market, which successfully matched the CPSC requirements. This feat once more underscored Aptar Pharma’s worldwide reputation as an innovative leader and trusted partner in the pharmaceutical industry.

Aptar Pharma’s Child-Resistant Feature for nasal sprays effectively combines Child-Resistance (CR) and Senior-Friendliness (SF) with its intuitive and widely-accepted squeeze-and-turn technology. The positive market feedback and increasing demand for the Child-Resistant Feature over the last two years demonstrates that Aptar Pharma’s CRSF technology is the best-in-class solution available on the U.S. market. As of today, all major brands of nasal decongestant topical sprays in the U.S. come with Aptar Pharma’s Child-Resistant Feature.

According to Alex Theodorakis, President Aptar Pharma North America, “We are pleased to welcome the arrival of Aptar Pharma’s Child-Resistant assembly machine to our recently-expanded Congers, NY manufacturing site. This added manufacturing capacity enables us to offer the production of this key Child-Resistant/ Senior-Friendly feature to our customers domestically. Being closer to our customers continues to be of strategic importance to Aptar Pharma, and this new initiative enables us to continue to support our important North American marketplace and increase our demand reactivity.”
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Aptar Pharma Congers site, NY – Courtesy of Aptar Pharma

Nemera announces a research agreement with UFRT (University of Tours) on new nasal drug delivery treatments

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Nemera and the Research Center for Respiratory Diseases (CEPR) of Tours University (INSERM U1100) join forces in a partnership to enhance drug therapeutic effectiveness in the nasal cavity.

The number of applications through the nasal route is expanding. The development of systemic medicinal products through the nasal mucosa is increasing, as well as new treatments directly targeting the central nervous system (nasal administration allows avoiding the blood-brain barrier). The nasal route of administration is easily accessible; it allows a focused efficacy and an outstanding usability, making patients’ lives easier than other types of treatments.

The purpose of this partnership is to develop a new method of nasal administration.

This collaboration relies on the expertises of Tours University in respiratory pre-clinical and clinical research, as well and Nemera’s experiences in development of drug delivery devices.

Sanner GmbH has acquired Jaco S.A., based in Kirchheim, France. Through the merger Sanner now advances to the global market leader for effervescent packaging.

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Sanner is known as market leader for desiccant packaging in the global pharmaceutical and healthcare sector. The company Jaco S.A. is one of the leading manufacturers of printed and unprinted plastic tubes for effervescent tablets. “Our product portfolios complement each other ideally,” says Dirk Mähr, Managing Director of Sanner GmbH. “As a result of the merger, we have significantly strengthened our market position and have become the world market leader for effervescent packaging.” In 2016, Sanner generated annual sales of 63.7 million Euros, while Jaco S.A. achieved around 13 million Euros.

“Together, we offer our customers one of the most comprehensive ranges of tubes and closures, combined with numerous decoration possibilities. This allows us to operate as a system supplier in the future,” says Tharcisse Decker, Managing Director of Jaco S.A. “Apart from the strong French and European market, we are now also able to enter new markets such as the Middle East or Africa more effectively,” Dirk Mähr adds. Moreover, Jaco S.A.’s experience in printing technology can be used for new products, while Sanner’s competencies in research and development are of great advantage for joint, innovative projects.

The acquisition will have no effect on the employees or the production of both companies. Customers will be served by the sites in Bensheim and Kirchheim. The company name Jaco S.A. will remain unchanged for the time being. The former owners of Jaco S.A have withdrawn from business. The parties agreed on keeping the purchase price confidential.

New ISO 7 injection-blow moulding line at Union Plastic: UP PHARM® bottle

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For the last 60 years, Union Plastic has been renowned for its expertise in the field of plastic injection moulding particularly targeting the healthcare sector and, at the present time, offers the healthcare industries high-quality plastic products, ranging from dosing systems, to medical devices and including consumables for in vitro diagnostics. The company has just been equipped with a new injection-blow moulding line in an ISO 7 class environment for the manufacturing of a new bottle: UP PHARM®.

Union Plastic has made innovation a central priority for the last 2 years and, as such, has added a new area of expertise to its arsenal, injection-blow moulding. With this expertise, the company is now in a position to develop LDPE, HDPE and PE plastic bottles of volumes varying from 5 to 100 ml.

The first part of this electric machine is a pre-injection plastic processing section. The second consists of a triangular turret where, simultaneously, a first mould injects plastic to form preforms while another mould blows previously manufactured preforms unidirectionally so as to give them a hollow shape. Finally, at the same time, on the last side of the triangle, the hollow bottles manufactured using the first two moulds are ejected. These two moulds are characterised by their horizontal closure, unlike plastic injection moulds which are closed vertically.

Union Plastic now offers the supply of bottles blow-moulded with controlled processes, entirely in an ISO 7 class environment as per NF EN ISO 14644-1:2016. Blower ceilings equipped with high efficiency filters protect the zone where parts are injected. The parts are subsequently conveyed into an ISO 7 room for assembly and packaging.
This ISO 7 class environmental conditions are equivalent to Good Pharmaceutical Manufacturing Practices Class C. This particulate cleanliness is a real advantage for the healthcare sector since ISO 7 class bottle production makes it possible to reduce residual endogenous endotoxins after sterilisation.

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This distinctive offering can now compete with the rare panel of bottle suppliers who offers such an ISO 7 class quality level.

With this advantage, Union Plastic is targeting the ophthalmic and self-medication market, particularly bottles intended for the nose, mouth and ears containing active ingredients sensitive to ambient bacteria such as antiseptics or antibiotics.
A range of catalogue products is under development and will expand the offering of blow-moulded bottles
for the healthcare sector.

Sarepta Therapeutics Opens its Research and Manufacturing Center at Andover

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Sarepta Therapeutics, a U.S. commercial-stage biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare neuromuscular diseases, has announced the grand opening of its Research and Manufacturing Center in Andover, Massachusetts.

The 60,000 square foot state-of-the-art facility significantly enhances Sarepta’s research and manufacturing capabilities as it expands its global commercial footprint and rapidly advances its Duchenne muscular dystrophy (DMD) pipeline, which comprises a robust exon skipping platform, and next generation approaches such as gene therapy and utrophin upregulation programs. The current focus of the manufacturing facility will be to advance Sarepta’s development pipeline and research programs. By the end of the year, Sarepta could have up to seven investigational DMD treatments in the clinic.

Ultimately, Sarepta’s goal is to help as many individuals with DMD as possible. To support this objective, Sarepta plans to expand its headcount in Andover by 100 percent over the next 12 to 18 months, adding to the approximately 50 employees currently based in Andover.

“Since first moving to Massachusetts in 2013, Sarepta has benefited enormously from the Commonwealth’s talented and highly-educated workforce,” said Edward Kaye of Sarepta. “This expansion underscores our ongoing commitment to patients with Duchenne and investment in the vibrant Massachusetts economy. We are grateful to Governor Baker, the Massachusetts Life Sciences Center, MassBio, the Town of Andover, and other state and local officials who support our mission to serve the greater DMD community.”

System pharmacology modelers throw light on drug discovery in Alzheimer’s

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InSysBio scientific group led by Tatiana Karelina developed a quantitative system pharmacology model of Alzheimer’s disease. First part published in CPT PSP shows how to design initial phases of clinical trials of new drugs and to interpret the data obtained.

Alzheimer’s is a chronic neurodegenerative disease which leads to the senile cognitive impairment and memory loss. Every third person older than 70 years suffers from it. Such changes are caused by functional disorders and subsequent death of neurons. However triggers of processes resulting in brain cell death are still remain unknown. That’s why there is no effective therapy for Alzheimer’s disease.

At the moment, the most common hypothesis is a theory of the toxic effect of the beta-amyloid protein, which accumulates in the brain with age, aggregating into insoluble amyloid plaques. The presence of these plaques in the brain is the main marker of Alzheimer’s disease (unfortunately, often found postmortem). Soluble (not aggregated into plaques) forms of the protein are considered to be toxic too.

All modern therapies act in one of the three ways: they can block production of soluble beta-amyloid, destruct protein before transformation into insoluble form, or to stimulate the plaque degradation. “Clinical trials for Alzheimer’s therapies have got one significant feature – their short duration. They last for no more than 5 years, whereas the disease can progress for decades. And early Phase I-II tests last for only few weeks. With such experiment design one can affect only on the processes of distribution and degradation of the soluble beta-amyloid forms. Therefore we developed this part of our model to analyze and predict the dynamics of the new generation of drugs, for instance the inhibitors of amyloid production”, says Tatiana Karelina, the head of the neurodegenerative disease modeling group, InSysBio LLC.

The first difficulty encountered by drug developers is the interpretation of the results obtained in animal tests. In general, most studies of the distribution of amyloid are carried out on mice: scientists inject a labeled protein into the mouse brain and observe the distribution of the radioactive label. Alternatively, the dynamics of amyloid in the presence of drugs is studied. Based on the data obtained, researchers can calculate the “therapeutic window” for the medication – a range of doses from the minimum effective to the maximum non-toxic. Then doses for human or monkey are calculated by using mass or volume scaling (for the body, the parameters change as many times as its mass or volume is greater than the mass or volume of the mouse).

The project team collected the data from the literature and derived a system of equations that fully described the existing results. Firstly the model was calibrated (i.e. the missing parameters were estimated) for the mouse, and then for the human and monkey. It turned out that one cannot use the scaling method to transfer results from rodents to primates (as it’s often done). The deduced mathematical equations have shown that not only the rate of production of beta amyloid (as activity of corresponding genes) differs, but moreover the blood-brain barrier is different in rodents and higher primates. At the same time, there was no significant difference between the human and the monkey, and the standard scaling can be used to translate predictions between them.

The next big question in Alzheimer’s clinical trials is how to understand if the drug affects specific target on the short term. It is impossible to observe the processes that occur in the human brain directly. Usually a cerebrospinal fluid probe is taken for analysis of the change in the concentration of beta-amyloid. Actually, these data strongly differ from the values of amyloid concentration in the brain, since the cerebrospinal fluid is strongly influenced by the processes taking place in the blood plasma, and amyloid demonstrates another dynamicsy.

“If there is such a big structural model calibrated on the big amount of data one can easily match the results of cerebrospinal fluid sample analysis with the real processes in the patient brain. This will greatly accelerate the development of new drugs and improve the accuracy of the therapy selection”, explains Tatiana Karelina.

Scientists report that their model allows to predict how these new drugs must be administered. Total daily dose can be diminished but should be split for several parts during the day, providing optimal brain efficacy. InSysBio team is confident that the systems-pharmacological modeling can greatly improve the development of drugs from Alzheimer’s disease and are already negotiating the introduction of technology with their partners in the pharmaceutical industry.