The Enterion Capsule is charged with drug and swallowed. When it reaches its destination in the gastrointestinal tract a radiofrequency signal activates a spring-controlled piston, which forces the drug out of the capsule and into the target tissue. A feedback mechanism tells the operator if the triggering mechanism has been successful. Following the Enterion Capsule within the GI tract and locating its released cargo is easy using gamma scintigraphy provided the drug is suitably labeled.
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Drug delivery technology DDT is increasingly important as a component of drug development. With an increasing diversity of compounds addressing more drug targets, the available range and sophistication of DDTs has expanded with the goal of increasing the successful rate of new chemical entities. Peptides, proteins, and nucleic acids face similar delivery challenges. Ravi Kiron, Ph. Most DDTs result in physical mixtures or entrapment of the active ingredient in a matrix within a dosage form, which can be solid, liquid including topical creams , or adhesive for most transdermal systems.
PEGylation, the covalent attachment of a drug substance to polyethylene glycol ranging in weight from 5 to 60 kDa, is a notable exception. The use of advanced DDT to enable the development or enhance the utility of drug substances is a key component of what has come to be known as Life Cycle Management LCM.
The goal of reformulation is to launch an improved patent-protected formulation in advance of expiration of the compound patent to prevent generic copies of the original product from almost immediately capturing virtually the entire market. Implementation begins at least five years in advance to ensure launch before patent expiration. LCM is now firmly embedded in the strategies of pharmaceutical and many biotech companies.
The importance of DDT as a component is not limited to the development and introduction of a new formulation shortly before the expiration of the compound patent. Proper LCM will silence industry critics who say companies introduce improved new formulations when the drug substance patent expires solely to protect a franchise.
Critics claim the new improved formulation that could have been of more benefit to patients if introduced much earlier in the product life cycle. LCM strategy includes the introduction of a single isomer form of racemic mixtures and fixed combination products.
The development of fixed combinations of two or more drugs has increased dramatically because of powerful driving forces and as a component of LCM. Jay S. Historically, the FDA was skeptical of fixed combinations, such as two or more drugs in the same dosage form, often citing titration difficulties and other technical challenges.
The result can be rational combinations that provide a significant medical advance and have commercial potential. He concluded that the commercial importance 14 of the top selling prescription products are fixed combinations, increasing FDA responsiveness, broader acceptance, technical advances, and contribution to LCM will continue to increase the importance of fixed combination drug products. The industry has aggressively developed combination products for the cardiovascular market to take advantage of the significant overlap in patient populations.
Five combinations of statins e. Other combinations of statins with antihypertensives and other cardiovascular are in development. The importance of DDT from a commercial perspective is apparent from the resources that pharmaceutical and biotech companies dedicate to the function. Pfizer often conducts multiple feasibility studies of candidate technologies to increase the probability of success and provide options for deal structure and negotiation with DDT companies.
According to Atul Ayer, Ph. Ian Wilding, Ph. He demonstrated the importance of human studies by showing the poor correlation between animal and human data. Pharmaceutical Profiles developed a novel technology, the Enterion capsule, to study absorption in the human intestines.
Subjects swallow an Enterion capsule, which consists of a drug reservoir, release mechanism, and electronics. Location of the capsule in the gut is assessed in real time using a sophisticated imaging technique, and a radio frequency RF signal is used to release drug at the desired location in the GI tract to study uptake.
He sees permeability improvement as the biggest opportunity. Although some of these technologies have been utilized for years, recent improvements have enhanced their utility. Gastric retention, the use of DDT to prolong the residence and release of orally administered drug substance in the upper GI tract, has long been considered a desirable mechanism to increase the duration of action of small molecule therapeutics that have a narrow absorption window in the upper GI tract.
Historical results have not met this need. Bret Berner, Ph. Our formulations provide particles mm in diameter, just too large to cross the pylorus in the fed stomach. Each has been studied in over 1, patients and both products have received approval by the FDA. While no one was claiming oral delivery of peptides and proteins, the long-awaited inhaled formulation of insulin may be close to market. Many other inhaled formulations of insulin and other peptides and proteins are in development.
Wilding is one of many who believe that the first approval of a protein delivered with a novel delivery will favorably impact the market.
PEGylation technology has improved the delivery of injectable proteins. According to Mary Bossard, Ph. One PEG molecule is bound to a lysine on each alpha-interferon, providing high in vivo efficacy.
The manufacturing process can be controlled to produce microspheres from 0. Epic has developed Promaxx formulations of insulin, alphaantitrypsin, and hGH for pulmonary delivery.
Most of the development has been conducted with dry powder inhalers, a limited amount with HFA-based inhalers. The target particle size depends on the desired site of uptake. For example, microspheres 13 microns in diameter containing insulin are targeted to the alveoli for systemic delivery. Hydrophilic drugs, including some small molecules, peptides, and proteins, which cannot be delivered by conventional transdermal systems, provide much larger market opportunities. According to Eric Tomlinson, Ph.
Companies developing advanced transdermal systems to deliver these drugs include Altea Therapeutics and TransPharm Medical Lod, Israel. Both companies use small handheld devices that impart painless electrical impulses to create pores in the SC.
A patchlike reservoir containing the drug is placed over the treated area. The broader capabilities of these technologies include delivery of larger molecules and those with physico-chemical characteristics that would preclude passive delivery. Each company has worked with both small molecules and proteins, including insulin. Judith Kornfeld, vp, business development, TransPharma Medical, spoke on ViaDerm, which uses radio frequency current, to open microchannels in the SC, enabling transdermal delivery.
RF current is commonly used in other medical applications such as electrosurgery. The pores provide many small passageways through which a dissolved drug can cross the SC. The low-cost device may be used for 1, applications, nearly three years of once-daily treatment.
The device currently has microelectrodes per square centimeter, which may be modified for different delivery needs. In a recent clinical study, a patch of 8.
TransPharma has also shown therapeutically useful delivery rates for hGH. TransPharma has also worked on small molecules, including granisetron Kytril and testosterone. David Enscore, Ph. The poration array is a disposable part of the delivery system and comprises filaments per square centimeter.
The application device is reusable with a lifetime of up to two years. Roger Aston, Ph. We have a range of procedures to load drugs into the honeycomb. PSivida is developing BrachySil as a brachytherapy device as its first commercial product.
Brachytherapy is a radiation therapy in which radioactive material sealed in needles, seeds, or wires is placed directly into or near a tumor. BrachySil is a suspension of micron particles of highly purified BioSilicon containing immobilized 32P administered through a fine needle directly into the tumor and emitting beta radiation. A Phase IIa trial of patients with inoperable liver cancer showed no adverse effects or leakage of 32P from the implantation site.
BrachySil remains in the tumor, emitting beta radiation. Mean tumor regression was up to 80, some tumors of less than 4.
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Formulation tech goes Enterion
Drug delivery technology DDT is increasingly important as a component of drug development. With an increasing diversity of compounds addressing more drug targets, the available range and sophistication of DDTs has expanded with the goal of increasing the successful rate of new chemical entities. Peptides, proteins, and nucleic acids face similar delivery challenges. Ravi Kiron, Ph.
COLON-SPECIFIC DELIVERY – Toward Reliable Colon-Specific Drug Delivery
Capsule targets drug delivery within GI tract