Pharmaceutical P.I.N. Points Patent Innovation News Nov/Dec 2023

The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office in August-September, 2023.

High Concentration Antibody- Containing Lipid Formulation;  T. Morichika, D. Kameoka, Y. Imaeda, T. Maeda, O. B. Stauch; Chugai Seiyaku Kabushiki Kaisha, Japan and Hoff mann-La Roche, USA; U.S. Patent # 11,767,363; September 26, 2023.

In general, formulations containing antibodies are lyophilized and have high drug concentration. These formulations tend to be viscous. The inventors developed a formulation which inhibited the dimerization and deamidation during long-term storage. The formulation of humanized anti-IL-6 receptor antibody MRA contains 0.005 to 3% surfactant (polysorbate 80), histidine buffer, pH 6.0, 50 to 300 mM of arginine and 10 to 50 mM of methionine. The formulation produces less than 2.70% dimer after storage at 40°C.

Abuse and Misuse Deterrent Transdermal Systems; D.J. Enscore, F. Tagliaferri, S.P. Damon, A. Smith, J. C. Gaulding; Nutriband, Inc., USA; U.S. Patent # 11,759,431; September 19, 2023.

There are many drugs which have the potential for intentional abuse or accidental misuse. Many transdermal systems have a significant excess of the therapeutic agent to ensure that a therapeutically effective amount of drug is delivered to the patient. This patent describes a transdermal system, which deters abuse and misuse. One can abuse transdermal systems by placing in the buccal cavity, chewing the patch or extracting the drug. The inventors added an aversive or pungent agent, such as capsaicin, in the patch backing. The aversive agent shows a biphasic release profile comprising an immediate release followed by an extended-release profile.

Methods for Fat Reduction or Elimination of Lipid Droplets; A.D. Widgerow and J.A. Garruto; Alastin Skincare, Inc., USA; U.S. Patent # 11,752,084; September 19, 2023.

The need for treatments effective at ameliorating skin laxity associated with body shaping and contouring procedures are rapidly growing. The peptide combinations of the embodiments can be employed in various types of topical formulations. The compositions for this comprise two different peptides: a dipeptide, tripeptide, or tetrapeptide in combination with a pentapeptide, hexapeptide or heptapeptide. These formulations improve skin barrier function. Formulations comprise niacinamide or hydroceramide and hydrogenated lecithin. Improved barrier functions are - protection against water loss, prevention of substances and bacteria penetrating into the body, and plumps skin by improved hydration. To facilitate application, the composition may be provided as an ointment, an oil, a lotion, a paste, a powder, a gel, or a cream.

Nicotine Tablet; B.P. Nielsen and K.A. Nielsen; Fertin Pharma, Denmark; U.S. Patent # 11,738,016; August 29, 2023.

The invention relates to an orally disintegrating nicotine tablet for nicotine craving relief comprising a pressed powder formulation. The tablet disintegrates within a period of less than 60 seconds upon oral administration that helps to employ nicotine more efficiently. The faster release provides effective nicotine craving relief but also minimizes burning in the throat. Also, the tablet facilitates user compliance with instructions, such as not swallowing or spitting within a given time period from oral administration. The pressed powder formulation comprises an amount of nicotine, a pH regulating agent, at least one polyol, and a disintegrant.

Lipid Nanoparticle Compositions and Methods for mRNA Delivery; B.C. Guild, F. DeRosa and M. Heartlein; Translate Bio, Inc., USA; U.S. Patent # 11,730,825; August 22, 2023.

Conventional DNA insertion techniques are commonly used to insert desired genetic information into host cells. But it has many deleterious effects too. The use of RNA is significantly safer, but is far less stable than DNA, especially when it reaches the cytoplasm of a cell where it gets exposed to degrading enzymes. The current patent describes the delivery of mRNA that encodes cytokines. The mRNA is encapsulated within PEG-modified cationic and non-cationic lipids such as DSPC, DOPE, etc.

Therapeutic Bandage; L. Silbart and T.D. Nguyen; University of Connecticut, USA; U.S. Patent # 11,745,001; September 5, 2023.

Patent describes a therapeutic bandage that includes a matrix and an array of biodegradable micro-needles. The bandage matrix includes a hydration layer and a sequestration layer. The role of the hydration layer is to absorb foreign agents removed from a skin infection or skin condition. The sequestration layer, which includes an antibody and a dye, is configured to bind to the foreign agents. Each of the microneedles includes a first layer that encapsulates a first immunomodulatory compound and a second layer that encapsulates a second immunomodulatory compound. The array of microneedles is configured to guide foreign agents affected by the first immunomodulatory compound, the second immunomodulatory compound, or the first and second immunomodulatory compounds from one or more skin layers of a user to the bandage matrix. The immunomodulatory compound establishes a chemotactic gradient within the one or more skin layers to the bandage matrix such that the bandage matrix absorbs and captures the foreign agents.

Solid Dosage Form Production; M.A. Alhnan and T.C. Okwuosa; University of Central Lancashire, Great Britain; U.S. Patent # 11,717,485; August 8, 2023.

Solid dosage forms are preferred mostly due to their ease of administration giving rise to better patient compliance, storability and transportability, and high stability. However, they are often more onerous to manufacture. The present disclosure utilizes 3-D printing technology, particularly fused filament fabrication (FFF) in conjunction with solid and/or liquid dispensers to produce solid dosage forms, such as pharmaceutical capsules. Such solid dosage forms have a shell, which is 3D printed, and a core, which is dispensed. The patent describes solid dosage forms obtainable by printing methods and apparatus, a package, a kit of parts, a computer for controlling the relevant printing process, a system for collecting data, and relevant blueprints for use in the printing of solid dosage forms.

Publication Detail

This article appeared in American Pharmaceutical Review:
Vol. 26, No. 8
Nov/Dec 2023
Pages: 86-87

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