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Oracle is a vendor of IT-related products and services such as servers, cloud solutions, database software, engineered systems and many more. Oracle also offers certification programs to individuals who want to validate their skills in providing the Oracle System Solutions. The certification program is divided into six levels, which are: - Oracle Certified Junior Associate (OCJA) This is a foundation level credential designed for high school students, college diploma students and university students. It also targets those who teach basic Java and Computer Science. Oracle Certified Associate (OCA) It’s designed for candidates with fundamental skills in working with Oracle products. This level is a prerequisite for the professional level certification.
Oracle Certified Professional (OCP) This certification is targeted at individuals who have demonstrated their advanced skills in working with Oracle products in a specific area. Oracle Certified Master (OCM) The professionals with this credential have already demonstrated their knowledge in performing complex tasks and answering complex questions. They usually go through a rigorous exam process that takes them through performance-based tasks. Oracle Certified Expert Professionals from this category have to prove their competence in specific technological niche areas. Their skills may range from foundational to highly advanced.
Oracle Certified Specialists Attaining this certification requires that the individuals can prove their experience in using specific products in implementing Oracle programs and solutions. All Oracle certifications fall into any of the nine available categories. These categories are: - Applications Certifications They include Agile, CRM, E-Business Suite, CPQ Cloud, and Peoplesoft, and others. Database Certifications This category includes MySQL and other Oracle add-ons and versions. Enterprise Management Certifications They include the Application Database Manager and Quality Management. Foundation Certifications They include Oracle Project Lifecycle Management and IT Architecture.
Industrial Certifications They cover areas such as Communications, Health Sciences, Financial Services, Insurance, Tax Applications, and Retail. Java and Middleware Certifications They cover Business Intelligence, Data Integration, Java, Cloud Application, Identity Management, Middleware Developing Tools, WebCenter, BPM, and SOA. Operating Systems Certifications They include Oracle Solaris (V10 and V11) and Oracle Linux. Systems and Hardware Certifications They cover Storage, Servers and Engineered Systems.
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All the certifications and individual exam details are available on the official website. To prepare for the exam, a candidate can make use of the available resources like instructor-led training, study guides, and practice tests. Since Oracle offers so many credentials numbering up to more than 300, the range of the job roles available is also wide. Some of these jobs are Oracle Cloud Analyst, Cloud Technology Consultant, Associate Java developer, Oracle Fusion Middleware Consultant, Oracle DBA Consultant, Junior Oracle Developer and Oracle DBS Developer, and others. Oracle’s expansive certification program has, without doubt, led to the popularity of their credentials and professionals. They are some of the highly sought after qualifications by employers who understand the value of the kind of experts that Oracle produces. Oracle professionals are able to work on any OS platforms like Linux and Windows.
Dosage form and formulation details rank among the more unique information provided by PharmaCircle. In this post we look at Oral Tablet weights as an introduction to the How Supplied Non-Injectable module using the Panorama interface. The How Supplied Non-Injectable module is found in the R&D section, clicking the P icon brings up the Panorama interface. So what is the distribution of weights for approved Oral Tablets? That turns out to be a pretty easy question to answer using the How Supplied Non-Injectable module, the Panorama interface and the Weight (mg) tab.
The chart below plots out the distribution of tablet weights. (Note: this doesn’t include oral tablets that are intended to be dissolved in water, or are orally dissolving tablets. These can be easily searched using separate terms.) Click on any chart or table to enlarge the view. The weight distribution of tablets peaks in the 100-200 mg range. What about the ‘monsters’ that are in the 1,000+ mg range? The PharmaCircle search reveals four marketed tablets, typically capsule/oval shaped tablets, with weights of more than 1,000 mg. The heaviest of these products, the 1000 EQ mg base formulation of Fosrenol, weighs in at 2.1 grams, but really shouldn’t be considered part of the group.
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It is intended to be chewed, not swallowed. The number one spot for heaviest tablet is effectively a tie between the 600mg dose form of Sustiva, weighing in at 1,230 mg and the 80 mg dosage form of Lipitor weighing in at 1,228 mg. The details of these products is presented in the table below. It’s interesting to note that the Lipitor 80 mg formulation is unique in having a surprisingly high 14:1 ratio of excipient to active. While there probably is a good reason for the formulation it does lead to a remarkably heavy tablet. The How Supplied Non-Injectable module provides for many other search opportunities related to product formulations including Dosage Form, Excipients, Color or Shape.
For assistance on using the is module, or any other, get in touch with, VP Operations, at PharmaCircle. He and his team are there to help.
There has been much discussion and concern in the United Sates about the toll that opioid abuse has taken on American society in terms of lost and wasted lives. What was largely an issue related to illegal drugs as recently as a decade ago has turned to concerns about the abuse of prescription pharmaceuticals, most notably opioids. The industry response has been to develop abuse deterrent and tamper resistant opioids, along with mandatory REMS (Risk Evaluation and Mitigation Strategy) programs. The hope is that these new formulations and REMS programs will reduce the deaths and the misery associated with opioid abuse and misuse. Perhaps though, part of the responsibility rests with the opioid formulations, their promotion, and how they are prescribed. That, at least, is the premise put forward in a Los Angeles Time article. Los Angeles Times Article The article, “‘You want a description of hell?’ OxyContin’s 12-hour problem” by Harriet Ryan, Lisa Girion and Scott Glover in the Los Angeles Time, May 5, 2016, suggests that OxyContin has contributed to the troubling increase in prescription opioid dependence and abuse.
The issue is best understood by reading the full article, but the nub of their argument is that OxyContin is not in fact a twelve hour medication, but provides a shorter duration of action in most people and requires dosing on an eight-hour interval. By failing to provide a full twelve hours of pain relief, patients are faced with a choice of enduring the pain, taking their next dose a earlier, or using supplemental analgesics, licit and illicit. So why not have the physician simply dose OxyContin q8h? The LA Times article suggests the issue rests with OxyContin’s approved prescribing label, and Purdue Pharma’s sales and marketing promotion of the product. Considerable reference is made in the article to Purdue Pharma repeatedly, and consistently, advising physicians to forego a q8h dosing schedule with patients.
Rather, the company has advised physicians to prescribe higher doses of OxyContin rather than shorten the time between doses. On the pharmacokinetics of the original OxyContin formulation claimed that steady state levels of oxycodone were reached within 24 hours after dosing was started with OxyContin.
Steady state implies relatively stable plasma levels. But in the real world it seems OxyContin, both the original and abuse deterrent formulation, doesn’t provide effective levels of analgesia for many patients through to the next dose suggesting that a steady state hasn’t been reached. Raising the dose, rather than reducing the dosing interval, can extend higher serum levels, but at the expense of higher peak serum levels and potentially greater ‘highs’ that can lead to opioid intoxication or euphoria. The patient may no longer be simply taking an analgesic, but also a mood influencing drug.
For some this might well be the start of a very slippery slope where they might not only look for extended pain relief, but also the pleasure of the ‘high’. This seems to be the case in a number with a number of individuals presented in the LA Times article.
The Pharmacokinetics of OxyContin, Xtampza ER and Duragesic The recent approval of Collegium’s Xtampza ER in April 2016 provides some insights into the pharmacokinetics of not only Xtampza ER, but also OxyContin, as found in the. The information provided in the FDA Xtampza ER and OxyContin review documents unfortunately provide little information into the pharmacokinetics of these products when administered chronically, or the consequences of missed or skipped doses. This chart below taken from the Xtampza ER NDA approval package plots the single dose fasting and fed serum levels of oxycodone when Xtampza ER 40mg or OxyContin OTR 40mg was administered to healthy volunteers (page 5, Reference ID 3816317). While there is a difference in the magnitude of the peak serum levels depending on the drug administered and the fed status of the healthy volunteers, the general shapes of the curves appear similar. The chart below (Page 7, Reference ID: 3816317), provides additional, albeit limited, insight into the ‘steady state’ levels of both Xtampza ER and OxyContin OTR when dosed chronically, for at least five days, with fasted and fed volunteers.
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Both Xtampza ER and OxyContin claim in their labeling claim that steady state levels are reached within 24 to 36 hours after dosing is started. Looking at the charts below it seems that even after steady state has been achieved there is still as much as a 3-fold swing in the minimum and maximum oxycodone serum levels. If we assume the serum level for effective analgesia is 30ng/ml it is apparent that patients will spend about two-thirds of the dosing period with levels in excess of this amount, and one-third of the time below this level, especially if a dose is taken in a fasted state.
Compare this with the serum levels of fentanyl seen with Duragesic, a transdermal formulation of fentanyl dosed every three days, when administered chronically. The chart below is taken from the Duragesic package insert. While it takes up to three days to achieve stable steady state levels, from that point onward there is less than a 50% excursion in fentanyl serum levels going forward.
The onset of action of Duragesic seems to be slow and steady, without the peaking seen with the two controlled release oxycodone products. A transdermal product is also likely to be affected by the food effects that seem to impact Xtampza ER and OxyContin. The mean level presented in the Duragesic chart above most reasonably represents the ‘average’ experience. The large variation seen in the chart represents the difference in individual patient serum levels. The higher and lower serum levels plotted above are consistent with different patients rather than individual patients experiencing wide fluctuations as is more apparent when viewing the individual patient data from the original 1990 (below). Reflections Perhaps these two approved controlled release oxycodone analgesics, Xtampza ER and OxyContin OTR, are being prescribed for the wrong indications.
These SR products, while reducing the peak and trough serum levels seen with immediate release opioids, may be most appropriate for acute indications requiring treatment for a week or less, perhaps on a q8h dosing schedule. Chronic conditions, requiring extended analgesia, are perhaps better with transdermal opioids, like Duragesic, that provide full 24-hour analgesia with limited variations in serum levels that may lead to drug seeking behavior.
If you have been following the OxyContin generic story over the last decade and a half, you will recall that an important foundation of the OxyContin patent claims rest on the product’s pharmacokinetic profile and it’s q12h dosing. Does promoting dose escalation rather than dosing interval reduction provide the necessary support for OxyContin’s intellectual property position?
Do higher doses rather than a reduced dosing interval impact how willing insurers are to reimburse the product as suggested in the LA Times article? Raising the dose or reducing the dosing interval really doesn’t make much of difference in terms of sales, given that OxyContin is priced on a per milligram basis rather than a price per tablet independent of actual dose content. Two-a-day 60mg or three-a-day 40mg results in the same 120 mg daily dose, with minimal impact on cost and profit. Conducting pharmacokinetic and clinical trials looking at q8h dosing with the existing OxyContin formulation would have been a trivial cost in relation to the billions of dollars in revenue the product had earned. There is no question that OxyContin and OxyContin OTR are well formulated products. They provide for an extended duration of action relative to immediate release opioids and seemingly have no stability issues. But are they the right product for the treatment of chronic pain as suggested by the authors of the Los Angeles Times article?
With the approval of Xtampza ER it seemed possible that this new sustained release oxycodone formulation might provide a true 12-hour duration of action promised by OxyContin. Looking at the comparative pharmacokinetics of the two products it’s hard to imagine that it will perform any different than OxyContin. Given America’s love of oral dosage forms it seems there still exists a need, and an opportunity, for a company to develop an oral opioid that provides a true 12- or even 24-hour duration of action, dose after dose, after dose. Following along with our review of FDA Product Approvals, this week we look at Oral Product approvals over the 2004-2016 period. Oral is both a simple and complex term. For the purpose of this analysis we will consider Oral to be any pharmaceutical product that is introduced into the oral cavity without the benefit of a device. That includes traditional tablets, buccal and sublingual tablets and films, as well as troches, powders, oral liquids and oral sprays.
A total of 726 oral products (non-ANDA) were approved by the FDA in the period 2004 through 2016. In terms of approvals by dosage form delivered by the Oral route, Tablets lead, followed by Capsules, Liquids and Other.
The Other category includes oral sprays, powders for suspension and solution, and films. There doesn’t seem to be any apparent trend in terms of the FDA approval of modified release oral products in the period of 2004-2016 as seen in the chart below.
FDA approvals can only reflect submissions, so it seems that the Industry has not identified a steadily increasing number of products that might benefit from release modification. Alternatively, it could be that the industry is more discriminating in their selection of molecules so as to minimize the requirement for Formulation or Drug Delivery enabled dose modification. Because the FDA Product module provides somewhat limited product information we need to turn to the PharmaCircle Products & Pipeline module for information concerning drug delivery and formulation technologies such as nanoparticles, abuse deterrence, amorphous dispersions, spray drying or taste masking (‘formulation enhanced’). These are product enhancements that aren’t usually categorized using the standard FDA terminology. Doing a search of USA approvals, excluding generics, for the same 2004-2016 period returns with a similar total of 726 Oral product approvals.
A total of 181 products were labeled by PharmaCircle as being Modified Release. An additional 107 fit the criteria of ‘formulation enhanced’ products. The remaining 438 products did not incorporate any identifiable form of ‘modified release’ or ‘formulation enhanced’ technology intended to customize product performance. As a follow up to recent articles on 2016 FDA approvals it seemed appropriate to go back a few years and examine the trend over the intervening years with regard to NDA and BLA approvals. This post, taken from the PharmaCircle Newsletter, looks at FDA product approvals administered via the Inhalation Route. (The data used for this analysis was sourced from the PharmaCircle FDA Product module using the Flexible interface.) There were a total of 42 approvals over the thirteen years, an average of 3.2 per year. A least squares plot of the approval numbers by year reveals a slight upwards trend in approvals, albeit with a very low R-squared value.
The uptick seems to largely be a function of the recent approval of a refreshed portfolio of GlaxoSmithKline (Ellipta dry-powder) and Boehringer Ingelheim (Respimat soft mist) inhalation products. It’s possible to draw a line that provides for a larger R-squared value, but it cuts more curves than a slalom skier and doesn’t provide any greater insight. Interested in getting these Drug Delivery and Formulation insights when they are published in the PharmaCircle Newsletter? Sign up for the PharmaCircle Newsletter through.
In addition to getting these insights earlier you also get access to Kurt’s weekly drug delivery and formulation news summary, additional related information and occasional discounts to select conferences. Subscribing also provides access to the PharmaCircle Resource Center.
For information on subscribing to PharmaCircle please contact Tom (Global, South America, Asia, Africa) or Michael (North America) or Gavin (Europe) at. After a bit of work downloading and tidying up the approvals data from the PharmaCircle FDA Products module we now have Route and Dosage Form numbers for 2016 FDA NDA and BLA approvals. While much attention is placed on the overall number of FDA NME (New Molecular Entity) approvals there is much to be learned looking at the full breadth of NDA approvals, NME and formulation enhanced products (generally 505(b)(2) products).
There were a total of 112 NDA and BLA approvals in 2016 (excluding simple label extensions and such). In terms of Dosage Route the most common was Oral (45%) followed by Injection by one means or another (38%). The full list is presented in the tables below. (Note: the Route and Dosage Form designations are as assigned by the FDA.) Dosage Route Approvals Dosage Form Approvals For more information on and the FDA Product module contact. The numbers seem to suggest that patients really don’t like buccal formulations. That’s a simple conclusion after watching the market reaction to a number of buccal formulations of fentanyl and buprenorphine over the past ten years. The perception that buccal formulations don’t have a strong market acceptance was reinforced by Endo’s decision in December to return the US rights for Belbuca (buprenorphine) to BioDelivery Sciences (BDSI), despite having launched the product in early 2016, and paying $30 million upfront.
Presented as a reacquisition of rights by BDSI, it amounts to Endo admitting they made a mistake and cutting their losses. Belbuca is expected to capture net sales of less than $17 million in 2016, with a forecast increase to $21 million in 2017. This must be a disappointment for all concerned considering that the product competes in the multibillion dollar opioid analgesic market with a favorable Schedule 3 listing. The results for BDSI’s Bunavail (buprenorphine/naloxone for opioid dependence) are even more discouraging. Sales for 2016 were expected to come in at about $8 million, and grow to a forecast $11 million in 2017, while competing in a billion-dollar market. At the same time as these buccal formulations are failing to gain acceptance, comparable sublingual formulations are registering significant sales. The market leader, Indivior’s Suboxone (buprenorphine/naloxone) and Subutex (buprenorphine), will register close to a billion dollars in 2016 sales despite competition from generics.
Even Orexo’s Zubsolv Sublingual Tablets (buprenorphine/naloxone) is expected to ring up sales of $60 million in 2016 following a 2013 approval. A similar situation is seen with fentanyl buccal formulations. Onsolis (buccal film) lags with sales of a few million at best, while Abstral (sublingual tablet, $91 million sales in 2015, mostly Europe) and Subsys Spray (sublingual spray, $330 million sales in 2015), both prosper. It seems physicians and patients don’t care for formulations that involve sticking a tablet, or even a film, to the inside of the cheek that can take up to 30 minutes to dissolve. Is it an issue of films or the resident time in the mouth?
Suboxone is well accepted and it is administered as a film, often two, that is placed, or stuck, to the underside of the tongue. But it takes a bit more than 5 minutes to dissolve. Are buccal formulations that involve sticking a film or tablet to the cheek inherently unacceptable? That seems a reasonable conclusion after seeing a variety of buccal formulations, with different actives, consistently fail to capture market share.
The answer though may be in the development of buccal formulations that don’t require the better part of 30 minutes to deliver medication. But then again, why bother when there are sublingual technologies that can do this already? PharmaCircle Products & Pipeline Module This post was originally published in the PharmaCircle Drug Delivery and Formulation Newsletter, 2016-12-19.
To sign up for the newsletter head over to the r. The PharmaCircle FDA Approvals module offers a quick way to keep track of FDA approvals by month or year. The search results are presented using the FDA approved format which can be helpful, but also misleading.
A good example is the table below that summarizes the FDA approvals for the first quarter of 2016 and 2015. The label “Chemical Type” is the terminology used by the FDA to categorize their NDA approvals. It’s terminology that can be confusing for Drug Delivery & Formulation Professionals, especially when presented as in the table below. (Note: the Chemical Type listed as Other (Unclassified) is not an FDA term, in their listing of the relevant products they on occasion simply leave the Chemical Type field empty.) The figures above perhaps better reflect the performance of the pharmaceutical industry rather than the FDA.
While the FDA had a stellar year in 2015 in terms of approvals, they are dependent on the number and quality of the submissions they receive. As noted in the table, the four Other approved in 2015 were FDA approvals for the gases, Nitrogen, Helium, Oxygen and Medical Air, from three separate companies. Understanding the how the various “Chemical Type” labels are applied can be confusing.
What exactly is the difference between a “ New Formulation or New Manufacturer” and “ New Dosage Form”? In some cases a New Formulation or New Manufacturer approval involves a novel formulation approach, to wit, Neos’ Adzenys XR-ODT (add in PharmaCircle link), an extended release oral dissolving tablet formulation of amphetamine.
But in general, the majority of the NDA approvals categorized as New Formulation or New Manufacturer are simple dosage extensions such as an IV presentation, or a company entering the market with a me-too product or dosage form that is not eligible for ANDA (505(j)) review. This makes it hard to identify what the trends are with respect to new formulation product approvals.
It’s possible to manually compare 1Q2016 with 1Q2015 approvals with respect to products that incorporate more demanding formulation technologies. For the first quarter of 2016 the number is 5 approvals, versus 5 for the first quarter of 2015.
What is worth noting is that these formulation enhanced approvals represent a relatively small proportion of the total approvals in both 2016 and 2015. All products of course require some sort of formulation technology to ensure dose consistency and stability, but for the most part there is not a dependence on dose delivery modification. We’ll need to see if this is a trend going forward. A list of the 1Q2106 FDA approvals, not including generics, is provided in. Let me know if I may have overlooked anything. – Executive Editor. (From the, 2016-05-02).
The FDA’s approval last week of Collegium’s extended release capsule formulation of oxycodone, Xtampza ER, represents the first serious challenge to market leader Purdue’s OxyContin. Not only does Xtampza ER match up with OxyContin in terms of product features, it also received the FDA’s much coveted abuse deterrence labeling for Xtampza ER, previously enjoyed only by the reformulated OxyContin. It’s likely that Xtampza ER will cut into OxyContin’s profitability by grabbing market share and quite probably eroding prices. More interesting from a formulation perspective is the approach taken by Collegium.
Xtampza ER uses oxycodone base rather than a hydrochloride salt, and is presented in a capsule format containing sustained release microbeads. These wax-based multiparticulates are formed by spray congealing and are designed to resist particle size reduction and dose dumping when subjected to rigorous physical and chemical manipulation. This approach offers greater dosing flexibility while offering significant resistance to mechanical approaches intended to provide the immediate release of the active. Although formally approved in April 2016, Xtampza ER received tentative approval in November 2015. Final approval was subject to the resolution of infringement claims made by Purdue Pharma, which occurred in February with the U.S.
Court of Appeals for the Federal Circuit upholding an earlier decision to invalidate four Purdue patents. This cleared the way for the final approval of Xtampza ER in April. With these Purdue patents now out of the way the question has to be asked as to how soon we will see generic (505(j)) versions of OxyContin.
These generics will impact Xtampza ER as much as they will OxyContin. The question of course is what standards of abuse deterrence will the FDA require for approval of these generics. In terms of development time, it took about eight and a half years to move Xtampza ER from IND submission to tentative approval. Much of that time was doubtless spent on the many abuse deterrent trials. Xtampza ER is Collegium Pharmaceuticals first approved product. Through the end of 2015 Collegium has accumulated a net loss of $129 million, consistent with the net $100 million plus investment required by most other emerging formulation focused specialty companies to get a first product approved.
By most measures Collegium was not particularly speedy in their approval of Xtampza ER, but were reasonably frugal. Compare this with Pain therapeutics which has had their lead product Remoxy, another sustained release oxycodone formulation, in development for a decade and a half, and a net loss of $130 million despite significant deal income to fund operations. There are now three approved extended release oxycodone formulations with some degree of abuse deterrence approved by the US FDA. Xartemis XR, an oxycodone/acetaminophen combination product is at best a niche product with a single low dose dosage form. Information about PharmaCircle’s offerings is available by contacting. The Networkel's CCNP exam education exercise exam looks almost at the level most people create when they achieve all the possibilities in a 300-101 comparison. Our CCNP video frequency training system is available for purchase.
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