Philadelphia, Pennsylvania, United States
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Articles by Christopher
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Join a Live Webinar Interviewing Real World Drug Abusers Today at 1200 EST
Join a Live Webinar Interviewing Real World Drug Abusers Today at 1200 EST
By Christopher Altomare
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CAT.one™ - Abuse Deterrent Formulations
CAT.one™ - Abuse Deterrent Formulations
By Christopher Altomare
Activity
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Big shocker! the Pringles Doodoo strain and Smoothiesz didn’t meet their label claims. Both came with a generous helping of pesticides. Smoothiez…
Big shocker! the Pringles Doodoo strain and Smoothiesz didn’t meet their label claims. Both came with a generous helping of pesticides. Smoothiez…
Liked by Christopher Altomare
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Help me reach our fundraising goal. Your participation supports five Florida-based non-profit agencies providing essential services like medical…
Help me reach our fundraising goal. Your participation supports five Florida-based non-profit agencies providing essential services like medical…
Shared by Christopher Altomare
Experience & Education
Publications
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LABORATORY-BASED TESTING TO EVALUATE ABUSE-DETERRENT FORMULATIONS AND SATISFY THE FOOD AND DRUG ADMINISTRATION'S RECOMMENDATION FOR CATEGORY 1 TESTING
Journal of Opioid Management
The US Food and Drug Administration (FDA) considers the development of abuse-deterrent formulations of solid oral dosage forms a public health priority and has outlined a series of premarket studies that should be performed prior to submitting an application to the Agency. Category 1 studies are performed to characterize whether the abuse-deterrent properties of a new formulation can be easily defeated. Study protocols are designed to evaluate common abuse patterns of prescription medications…
The US Food and Drug Administration (FDA) considers the development of abuse-deterrent formulations of solid oral dosage forms a public health priority and has outlined a series of premarket studies that should be performed prior to submitting an application to the Agency. Category 1 studies are performed to characterize whether the abuse-deterrent properties of a new formulation can be easily defeated. Study protocols are designed to evaluate common abuse patterns of prescription medications as well as more advanced methods that have been reported on drug abuse websites and forums. Because FDA believes Category 1 testing should fully characterize the abuse-deterrent characteristics of an investigational formulation, Category 1 testing is time consuming and requires specialized laboratory resources as well as advanced knowledge of prescription medication abuse. Recent Advisory Committee meetings at FDA have shown that Category 1 tests play a critical role in FDA's evaluation of an investigational formulation. In this article, we will provide a general overview of the methods of manipulation and routes of administration commonly utilized by prescription drug abusers, how those methods and routes are evaluated in a laboratory setting, and discuss data intake, analysis, and reporting to satisfy FDA's Category 1 testing requirements.
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The ObGyn Clerkship: Are Students Denied the Opportunity to Provide Patient Care?
Connecticut Medicine
We sought to study the frequency, and reasons that third-year medical students on an ObGyn clerkship are denied the opportunity to be involved in patient care.
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D-optimal mixture design: Formulation development, mechanical characterization, and optimization of curcumin chewing gums using oppanol® B 12 elastomer as a gum-base
International Journal of Pharmaceutics
Curcumin (CUR) chewing gums have potential therapeutic benefits to head and neck cancer patients. The objective of this work was to develop medicated chewing gums (MCGs) with high CUR loading and desirable mastication properties. This was accomplished by evaluating the effect of five gum ingredients: (X1) polyisobutene, (X2) polyvinyl acetate, (X3) wood rosin, (X4) wax, and (X5) CUR on the mechanical properties of the MCGs using a 25-run, five-factor, two-level D-Optimal mixture design. CUR…
Curcumin (CUR) chewing gums have potential therapeutic benefits to head and neck cancer patients. The objective of this work was to develop medicated chewing gums (MCGs) with high CUR loading and desirable mastication properties. This was accomplished by evaluating the effect of five gum ingredients: (X1) polyisobutene, (X2) polyvinyl acetate, (X3) wood rosin, (X4) wax, and (X5) CUR on the mechanical properties of the MCGs using a 25-run, five-factor, two-level D-Optimal mixture design. CUR MCGs were prepared by the conventional fusion method for making chewing gums. They were characterized by a two-bites texture and uniaxial tension tests to generate force–displacement curves from which the cohesiveness (Y1), springiness (Y2), chewiness (Y3), compressibility (Y4), resistance to extension (Y5), and extensibility (Y6) were measured. Observed responses were used to generate polynomial models correlating the independent with the dependent variables. Elasticity and stiffness of the gums were found to be readily impacted by PIB and CUR levels. Fitted models were then used to predict a gum composition that has comparable mechanical properties to commercially procured chewing gums. The optimized MCG was loaded with 50% of either CUR or CUR/SBE-β-CD inclusion complex and tested in vitro for drug release. Although no differences in mechanical properties were observed, substituting CUR with the inclusion complex was found to significantly enhance drug release. This study highlighted the impact of each gum ingredient on the quality of the MCGs and demonstrated the feasibility of preparing chewing gums with up to 50% drug loading.
Other authorsSee publication
Courses
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Anatomy/Physiology I & II
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Biochemistry
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Calculus I & II
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Cancer Biology
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Fetal Development
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Genetics
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Linear Algebra
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Microbiology
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Modern Geometry
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Organic Chemistry I & II
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Pathophysiology
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Physical Chemistry I & II
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Physics I & II
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Probability and Statistics
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Organizations
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Cross Company Abuse Liability Council
Member
- PresentThe purpose of CCALC is to formulate and communicate scientific perspectives about medication abuse and its mitigation. The mission of CCALC is to improve public health by advancing the science of assessing abuse liability and potential across the product life cycle to promulgate best practices by working with regulators, academic researchers, and public policy advocates.
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NCIA
Member
- PresentNCIA is leading the charge to protect legal cannabis businesses, defend our state laws, and advance federal policy reforms. Successful businesses are joining NCIA every day to become stronger, smarter, and more prosperous by working together to defend and expand the responsible cannabis industry.
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ASPS
Member
- PresentAmerican Association of Pharmaceutical Scientists (AAPS) is a professional, scientific organization of approximately 7,000 individual members and over 10,000 actively participating stakeholders employed in academia, industry, government, and other pharmaceutical science related research institutes worldwide.
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Category 1 Focus Group
Co-Chair
- PresentDue to the very different nature of the Category 1 studies relative to the clinical studies, it was decided to initiate a focus group with people involved in Category 1 testing in order to have a forum where the study protocols, testing and interpretation of these data could be discussed. The group and meetings includes people from FDA, Academia and Industry including specialist consultants in Category 1 testing. This
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ASMS
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Dangerous trend of turning everyone into a dopamine rat. What I find most interesting is the skills needed to develop these technologies require deep…
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Thank you, WSJ for covering this important topic! For Marijuana Users, Even Legalization Doesn’t Guarantee Safety By Stephanie Armour…
Thank you, WSJ for covering this important topic! For Marijuana Users, Even Legalization Doesn’t Guarantee Safety By Stephanie Armour…
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🌱✨ Protect Your Harvest with Nova Analytic Labs! Dive into our latest blog on Pathogen Prevention in Cannabis. 🦠 Learn how silent threats like hop…
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"Lawmakers want answers from AG about Chinese ties to illicit weed farms". Click the link below to read the original story. The Chinese have…
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Lots of AI news, and it’s only the beginning of Jan! 2024 is going to be the year of AI at the edge. We’re not going to spend the year just chasing…
Lots of AI news, and it’s only the beginning of Jan! 2024 is going to be the year of AI at the edge. We’re not going to spend the year just chasing…
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Thrilled to partner with Sean Martin on Vynamic ‘s new Deal Activation & Partnership Enablement Service! Mergers, acquisitions, and partnerships…
Thrilled to partner with Sean Martin on Vynamic ‘s new Deal Activation & Partnership Enablement Service! Mergers, acquisitions, and partnerships…
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