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Poorly Soluble Drugs: The New Norm?

Amanda Stevenson-Grund - Thursday, February 22, 2018

An estimated 40% of approved drugs and nearly 90% of the developmental pipeline drugs consist of poorly soluble molecules. Several marketed drugs suffer from poor solubility.” – Kalepu and Nekkanti, Acta Pharmaceutica Sinica B. 2015; 5: 442

Circles represent drugs with improved solubility

Poor solubility affects the ability of a drug to be absorbed by the body, limiting the amount of drug available to create the intended action on the body. In the Biopharmaceutics Classification System (BCS), classes II and IV include poorly soluble drugs. According to a 2013 review article in the Journal of Developing Drugs, 38 percent of the top 200 oral drugs in the U.S. fall into BCS classes II and IV. Parenteral drugs also run into issues with solubility and overall, around 40 percent of all New Chemical Entities (NCEs) have poor solubility. For NCEs, poor solubility can result in drug development failure. Although this issue may seem insurmountable, there are techniques to improve solubility through the drug product or drug product intermediate’s formulation.

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Multiparticulate Dosage Forms Reduce Dose Dumping, Limiting Adverse Events

Amanda Stevenson-Grund - Friday, February 02, 2018

Multi-particulate dosage forms have several therapeutic and technological advantages over single-unit dosage forms, they can distribute evenly in the gastrointestinal tract, resulting in fewer adverse effects.” - Martínez-Terán et al. Pediatr Ther. 2017; 7:314

 A person clutches his or her stomach, representing adverse events

Even the best medications can have negative effects that affect a patient’s quality of life. However, your drug product’s format can positively affect the adverse event profile decreasing adverse events.

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Orbis Biosciences Announces Licensing Agreement with Reckitt Benckiser

Amanda Stevenson-Grund - Tuesday, January 02, 2018

Orbis Biosciences logo

Orbis Biosciences, Inc. announced today that it has entered into an exclusive global license agreement leveraging its Precision Particle Fabrication® technology. Reckitt Benckiser (RB), world-leading Consumer Healthcare company, and Orbis have entered into an exclusive cooperation agreement to develop and commercialize novel technologies in the field of consumer healthcare. The technology will enable new products for a leading segment of RB's product portfolio. Detailed financial terms were not disclosed.

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The Modified-Release Panacea: Multiparticulates

Amanda Stevenson-Grund - Friday, December 01, 2017

Among all the systems used for controlled release, multiparticulate systems are the most commonly used and can offer many unique advantages.” – Wen and Park, editors. Oral Controlled Release Formulation Design and Drug Delivery: Theory to Practice. John Wiley & Sons, 2011.

 Round spheres represent multiparticulates in drug delivery

Modified-release dosage forms have many formats: extended release, delayed release, sustained release, targeted release and pulsatile release. Each of these release profiles has potential drug formats to support creating the correct pharmacokinetic curve. Multiparticulates, in particular, are well-suited for modified-release applications. As stated by Jagdale, et al.,Multiparticulate systems offer various advantages over single unit systems.  These advantages include no risk of dose dumping, flexibility of blending units with different release patterns, as well as short and reproducible gastric residence times.”

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The Significance of Solubility in Oral Drugs

Amanda Stevenson-Grund - Friday, November 10, 2017

It is generally recognized that poor solubility is one of the most frequently encountered difficulties in the field of pharmaceutics.” – Kumar and Singh. American Journal of Pharmacological Sciences. 2013; 4: 67.

Two oral drugs in liquid indicate poor solubility

Many challenges slow the pace of drug development. One such challenge is drug solubility. Poor solubility causes low bioavailability and a decreased chance of drug administration resulting positive clinical outcomes.

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Orbis Biosciences awarded CPhI Excellence in Formulation Award

Amanda Stevenson-Grund - Monday, October 30, 2017

Orbis Biosciences receives a CPhI Pharma Excellence in Pharma Award

CPhI Worldwide, the world’s leading pharmaceutical and manufacturing conference, hosted more than 42,000 visitors October 24 -26 in Frankfurt, Germany. The event, which included more than 2,500 exhibitors from 153 countries, represents every sector of the pharmaceutical market. The culmination of this conference is the CPhI Excellence in Pharma Awards Gala where key industry innovations are recognized from across the globe for their innovative technologies.

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Intraympanic Injections Provide Local Delivery of Disease Fighting Drugs to the Inner Ear

Amanda Stevenson-Grund - Friday, October 13, 2017

Medicines, called antivirals, may decrease the risk of health problems and hearing loss in some infected babies who show signs of congenital CMV infection at birth.” – CDC, Cytomegalovirus (CMV) and Congenital CMV Infection. Accessed June 24, 2017

An ear represents antiviral, intratympanic drug delivery for cytomegalovirus

Cytomegalovirus can cause devastating long-term effects, such as hearing loss, for infants diagnosed with the disease. Physicians often use antiviral medication to treat cytomegalovirus by relying on systemic exposure of the drug to treat the infection. Emerging localized delivery approaches, such as intratympanic injection, offer the potential to provide incremental protection against the infection by delivering drugs directly to the inner ear.

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Diverse Responses to Cytomegalovirus Drive the Need for Population-Specific Treatment Approaches

Amanda Stevenson-Grund - Friday, September 29, 2017

Born This Way: Congenital Cytomegalovirus

Amanda Stevenson-Grund - Friday, September 15, 2017

About one out of every 200 babies are born with congenital CMV infection.”
CDC, Cytomegalovirus (CMV) and Congenital CMV Infection. Accessed May 6, 2017

Pediatric patients with congenital cytomegalovirus can experience physical disabilities

Most parents of newborn babies experience joy when welcoming a new member of the family. However, parents of children with congenital cytomegalovirus instead experience the fear that their children may be affected by the physical and intellectual disabilities that can accompany this disease. In very extreme cases, congenital cytomegalovirus can lead to death in newborns and young children.

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Strengthening Solubility: Advantages of Increased Drug Solubility

Amanda Stevenson-Grund - Friday, September 01, 2017

Poorly water-soluble drug candidates are becoming more prevalent. It has been estimated that approximately 60–70% of the drug molecules are insufficiently soluble in aqueous media,”Gupta et al., Formulation Strategies to Improve the Bioavailability of Poorly Absorbed Drugs with Special Emphasis on Self-Emulsifying Systems. ISRN Pharmaceutics: 2013; 2013


Poorly water soluble drugs continue to pose significant formulation challenges. Solubility challenges have driven CDMOs to employ a portfolio of technologies to address solubility challenges. 

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