company:hcl

Boeing’s 737 Max Software Outsourced to $9-an-Hour Engineers - Bloomberg
►https://www.bloomberg.com/news/articles/2019-06-28/boeing-s-737-max-software-outsourced-to-9-an-hour-engineers

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In offices across from Seattle’s Boeing Field, recent college graduates employed by the Indian software developer HCL Technologies Ltd. occupied several rows of desks, said Mark Rabin, a former Boeing software engineer who worked in a flight-test group that supported the Max.

The coders from HCL were typically designing to specifications set by Boeing. Still, “it was controversial because it was far less efficient than Boeing engineers just writing the code,” Rabin said. Frequently, he recalled, “it took many rounds going back and forth because the code was not done correctly.”

Boeing’s cultivation of Indian companies appeared to pay other dividends. In recent years, it has won several orders for Indian military and commercial aircraft, such as a $22 billion one in January 2017 to supply SpiceJet Ltd. That order included 100 737-Max 8 jets and represented Boeing’s largest order ever from an Indian airline, a coup in a country dominated by Airbus.

Based on resumes posted on social media, HCL engineers helped develop and test the Max’s flight-display software, while employees from another Indian company, Cyient Ltd., handled software for flight-test equipment.

C’est beau comme tout la langue de bois des public relations :

Boeing said the company did not rely on engineers from HCL and Cyient for the Maneuvering Characteristics Augmentation System, which has been linked to the Lion Air crash last October and the Ethiopian Airlines disaster in March. The Chicago-based planemaker also said it didn’t rely on either firm for another software issue disclosed after the crashes: a cockpit warning light that wasn’t working for most buyers.

“Boeing has many decades of experience working with supplier/partners around the world,” a company spokesman said. “Our primary focus is on always ensuring that our products and services are safe, of the highest quality and comply with all applicable regulations.”

In a statement, HCL said it “has a strong and long-standing business relationship with The Boeing Company, and we take pride in the work we do for all our customers. However, HCL does not comment on specific work we do for our customers. HCL is not associated with any ongoing issues with 737 Max.”

Starting with the 787 Dreamliner, launched in 2004, it sought to increase profits by instead providing high-level specifications and then asking suppliers to design more parts themselves. The thinking was “they’re the experts, you see, and they will take care of all of this stuff for us,” said Frank McCormick, a former Boeing flight-controls software engineer who later worked as a consultant to regulators and manufacturers. “This was just nonsense.”

Sales are another reason to send the work overseas. In exchange for an $11 billion order in 2005 from Air India, Boeing promised to invest $1.7 billion in Indian companies. That was a boon for HCL and other software developers from India, such as Cyient, whose engineers were widely used in computer-services industries but not yet prominent in aerospace.

La sous-traitance logicielle peut-elle suivre les modèles de la sous-traitance de l’industrie ?

HCL, once known as Hindustan Computers, was founded in 1976 by billionaire Shiv Nadar and now has more than $8.6 billion in annual sales. With 18,000 employees in the U.S. and 15,000 in Europe, HCL is a global company and has deep expertise in computing, said Sukamal Banerjee, a vice president. It has won business from Boeing on that basis, not on price, he said: “We came from a strong R&D background.”

Still, for the 787, HCL gave Boeing a remarkable price – free, according to Sam Swaro, an associate vice president who pitched HCL’s services at a San Diego conference sponsored by Avionics International magazine in June. He said the company took no up-front payments on the 787 and only started collecting payments based on sales years later, an “innovative business model” he offered to extend to others in the industry.

The 787 entered service three years late and billions of dollars over budget in 2011, in part because of confusion introduced by the outsourcing strategy. Under Dennis Muilenburg, a longtime Boeing engineer who became chief executive in 2015, the company has said that it planned to bring more work back in-house for its newest planes.

#Boeing #Sous-traitance #Capitalisme #Sécurité #Logiciel

Boeing’s 737 Max Software Outsourced to $9-an-Hour Engineers - Bloomberg
►https://www.bloomberg.com/news/articles/2019-06-28/boeing-s-737-max-software-outsourced-to-9-an-hour-engineers

https://assets.bwbx.io/images/users/iqjWHBFdfxIU/iz16OoABF9HQ/v0/1200x800.jpg

• Planemaker and suppliers used lower-paid temporary workers
• Engineers feared the practice meant code wasn’t done right

It remains the mystery at the heart of Boeing Co.’s 737 Max crisis: how a company renowned for meticulous design made seemingly basic software mistakes leading to a pair of deadly crashes. Longtime Boeing engineers say the effort was complicated by a push to outsource work to lower-paid contractors.

The Max software — plagued by issues that could keep the planes grounded months longer after U.S. regulators this week revealed a new flaw — was developed at a time Boeing was laying off experienced engineers and pressing suppliers to cut costs.

Increasingly, the iconic American planemaker and its subcontractors have relied on temporary workers making as little as $9 an hour to develop and test software, often from countries lacking a deep background in aerospace — notably India.

In offices across from Seattle’s Boeing Field, recent college graduates employed by the Indian software developer HCL Technologies Ltd. occupied several rows of desks, said Mark Rabin, a former Boeing software engineer who worked in a flight-test group that supported the Max.
[…]
In one post, an HCL employee summarized his duties with a reference to the now-infamous model, which started flight tests in January 2016: “Provided quick workaround to resolve production issue which resulted in not delaying flight test of 737-Max (delay in each flight test will cost very big amount for Boeing).”

United States Patent : 9861628
▻http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=98,61,628.PN.&OS=PN/98,61,628&RS=PN/98,61,628

Buprenorphine-wafer for drug substitution therapy

Abstract

The present invention relates to oral pharmaceutical dosage forms comprising buprenorphine with the dosage form releasing buprenorphine instantly upon oral, preferably sublingual, application of the dosage form. The present invention also relates to the use of such dosage forms for treating pain in a human or animal or for drug substitution therapy in drug-dependent human subjects.

BACKGROUND OF THE INVENTION

Chronic pain, which may be due to idiopathic reasons, cancer or other diseases such as rheumatism and arthritis, is typically treated with strong opioids.

Over the last decades prejudices in the medical community as to the use of strong opioids for treating chronic pain in patients has significantly decreased. Many of the se prejudices were due to some of the characteristics being inherent to opioids.

While opioids have always been known to be useful in pain treatment, they also display an addictive potential in view of their euphorigenic activity. Thus, if opioids are taken by healthy human subjects with a drug seeking behaviour they may lead to psychological as well as physical dependence.

These usually undesired characteristics of opioids can however become important in certain scenarios such as drug substitution therapies for drug addicts. One of the fundamental problems of illicit drug abuse by drug addicts ("junkies") who are dependent on the constant intake of illegal drugs such as heroin is the drug-related criminal activities resorted to by such addicts in order to raise enough money to fund their addiction. The constant pressures upon addicts to procure money for buying drugs and the concomitant criminal activities have been increasingly recognised as a major factor that counteracts efficient and long-lasting withdrawal and abstinence from drugs.

Therefore, programmes have been developed, particularly in the United States and western European countries, in which drug addicts are allowed to take prescription drugs under close supervision of medical practitioners instead of illegal drugs such as street heroin.

The aim of drug substitution theory is thus to first enable addicts to lead a regular life by administering legal drugs to prevent withdrawal symptoms, but because of their legal character and prescription by medical practitioners do not lead to the aforementioned described drug-related criminal activities. In a second and/or alternate step in the treatment of drug addiction may be to slowly make the drug addict less dependent on the drug by gradually reducing the dose of the substitution drug or to bridge the time until a therapy place in a withdrawal programme is available.

The standard drug used in drug substitution therapy programmes has for a long time been methadone. However, in recent years the potential of other opioids as substitution drugs in substitution therapy has been recognised. A particularly suitable drug for that purpose is the opioid buprenorphine, which is a mixed opioid agonist/antagonist.

Nowadays, buprenorphine preparations are administered in drug substitution programmes in the form of a tablet for sublingual administration. One of the reasons that the tablets are formulated for sublingual administration is that this the preferred route of administration for buprenorphine. Furthermore, if a patient swallows such tablets they will not provide euphorigenic activity.

One example of sublingual tablets for drug substitution therapy is the preparation Subutex.RTM. (being marketed in Germany by Essex Pharma).

Nevertheless, drug addicts sometimes still try to divert these sublingual buprenorphine tablets by removing them from the mouth when the supervising healthcare professional’s attention is directed to other activities. Later the tablets may be sold or the active agent buprenorphine isolated/extracted to apply it parenterally.

Another buprenorphine preparation aimed at preventing this potential possibility of abuse has recently gained administrative approval in the United States (Suboxone.RTM.). The Suboxone.RTM. preparation comprises buprenorphine hydrochloride and the opioid antagonist naloxone hydrochloride dihydrate. The presence of naloxone is intended to prevent parenteral abuse of buprenorphine as parenteral co-administration of buprenorphine and naloxone in e.g. an opioid-dependent addict will lead to serious withdrawal symptoms.

However, there remains a need for other diversion and/or abuse-resistant dosage forms of buprenorphine, which can be used in drug substitution therapy as described above. Additionally, it would be desirable to have a buprenorphine preparation available which is diversion and/or abuse-resistant in cases where the preparation is used for drug substitution therapy and which could also provide efficient analgesia in cases where the preparation is administered to alleviate pain in a patient.

OBJECT AND SUMMARY OF THE INVENTION

It is an object of the present invention to provide an oral pharmaceutical dosage form of the active agent buprenorphine that is less prone to diversion and/or abuse in drug substitution therapy. It is another object of the present invention to provide an oral dosage form of the active agent buprenorphine that can be used for drug substitution therapy and/or pain treatment.

In one embodiment the present invention relates to an oral pharmaceutical dosage form comprising at least buprenorphine or a pharmaceutically acceptable salt thereof with a dosage form releasing buprenorphine or said pharmaceutically acceptable salt thereof instantly upon or oral, preferably sublingual, application of the dosage form. It is, however, understood that the invention and its various embodiments which are set out below, can be extended to any opioid or analgesic whose preferred route of administration is oral, prefereably sublingual, as is the case for buprenorphine.

An instant release of buprenorphine or a pharmaceutically acceptable salt thereof upon oral, preferably sublingual, application means that substantially all of the buprenorphine or said pharmaceutically acceptable salt thereof will be released within less than three minutes, preferably within less than two minutes or less than one minute. Even more preferably, substantially all of the buprenorphine or said pharmaceutically acceptable salt thereof will be released within less than thirty seconds, twenty seconds, ten seconds or even within less than five seconds after oral, preferably sublingual, application of the dosage form. In one of the preferred embodiments these oral dosage forms will comprise between approximately 0.1 mg and approximately 16 mg buprenorphine or the equivalent amounts of a pharmaceutically acceptable salt thereof.

In a further preferred embodiment these oral pharmaceutical dosage forms will achieve an average C.sub.max of between 1.5 ng/ml and approximately 2.25 ng/ml in the case of a dose of 0.4 mg buprenorphine hydrochloride being administered. In the case of a dose of 8 mg buprenorphine HCl being administered, the C.sub.max will typically be between approximately 2.5 and 3.5 ng/ml and if a dose of 16 mg buprenorphine hydrochloride is administered the C.sub.max will preferably be between 5.5 to 6.5 ng/ml.

Yet another preferred embodiment of the invention relates to oral pharmaceutical dosage forms which may provide for the above-mentioned characteristics and/or an average Tmax of from approximately 45 to approximately 90 minutes.

In a particularly preferred embodiment the dosage forms will additionally comprise an opioid antagonist, preferably naloxone or a pharmaceutically acceptable salt thereof.

In yet a further preferred embodiment, the pharmaceutical dosage form will comprise buprenorphine and the opioid antagonist, which preferably is naloxone, in a weight ratio of from approximately 1:1 to approximately 10:1.

One embodiment of the present invention also relates to oral pharmaceutical dosage forms, which may have some or all of the aforementioned characteristics and wherein the dosage form has a film-like or wafer-like shape.

Another embodiment relates to a method of manufacturing the afore-mentioned described dosage forms.

Embodiments of the present invention also relate to the use of the afore-described oral, preferably sublingual, pharmaceutical dosage forms in the manufacture of a medicament for treating pain in a human or animal and/or for drug substitution therapy in drug-dependent human subjects.

One aspect of the invention also relates to a method of drug substitution therapy in drug-dependent human subjects wherein the aforementioned oral pharmaceutical dosage forms are administered to a drug-dependent subject in need thereof.

#Opioides #Sackler #Brevet #Cynisme #Capitalisme_sauvage