Disclosed are pharmaceutical compositions and oral dosage forms including capsules containing (17-β)-3-oxoandrost-4-en-17-yl tridecanoate, and related methods. The capsule fill can include an additive and about 14 wt % to about 42 wt % for androst-4-en-17β-ol-3-one esters that comprise (17-β)-3-oxoandrost-4-en-17-yl tridecanoate or a combination of (17-β)-3-oxoandrost-4-en-17-yl undecanoate, (17-β)-3-oxoandrost-4-en-dodecanoate, and (17-β)-3-oxoandrost-4-en-17-yl tridecanoate. A single oral administration to a male subject of one or more dosage forms with a total androst-4-en-17β-ol-3-one equivalent dose of about 150 mg to about 895 mg is provided. In another embodiment, a method for providing a serum concentration of androst-4-en-17β-ol-3-one within a target PK performance for a male subject is provided. In a further embodiment, the pharmaceutical compositions and methods comprising androst-4-en-17β-ol-3-one ester loading of 14 wt % to 42 wt % achieve androst-4-en-17β-ol-3-one PK performance targets and require titration(s) to show therapeutic effectiveness for treatment of hypogonadism.

Microemulsions are described where hydrophobic liquid droplets are distributed in a continuous hydrophilic liquid phase. The described microemulsions may be thought of as modified oil-in-water (MOIW) microemulsions, where both the “oil” and “water” phases of the microemulsion are modified. The oil phase droplets of the MOIW microemulsion are modified with alcohol and can solubilize alcohol-soluble species, including nonderivatized hormones. The polar continuous “water” phase of the MOIW microemulsion is modified with a sugar or sugar alcohol.

Microemulsions are described where hydrophobic liquid droplets are distributed in a continuous hydrophilic liquid phase. The described microemulsions may be thought of as modified oil-in-water (MOIW) microemulsions, where both the “oil” and “water” phases of the microemulsion are modified. The oil phase droplets of the MOIW microemulsion are modified with alcohol and can solubilize alcohol-soluble species, including nonderivatized hormones. The polar continuous “water” phase of the MOIW microemulsion is modified with a sugar or sugar alcohol.

Excipient compositions including a combination of excipients for mucoadhesive pharmaceutical compositions that improve mucoadhesiveness power, as well as release of and adhesion time of suitable active pharmaceutical ingredients (APIs) are disclosed. The excipient compositions include an aqueous solution with a synergistic combination of polymers, such as, for example amylopectin, pullulan, hyaluronic acid, and tamarind xyloglucan, among others. These polymers have been demonstrated to improve the release of as well as the adhesion time of APIs onto mucosa membrane. Mucoadhesive pharmaceutical compositions that include excipient compositions include suitable APIs, such as, for example analgesics, anesthetics, anthelmintics, anti-allergic agents, anti-fungals, antihistamines, anti-inflammatory agents, antimigraine agents, and hormones, among others. Mucoadhesive pharmaceutical compositions including excipient compositions are employed in the treatment of a plurality of mucous membrane diseases.

Excipient compositions including a combination of excipients for mucoadhesive pharmaceutical compositions that improve mucoadhesiveness power, as well as release of and adhesion time of suitable active pharmaceutical ingredients (APIs) are disclosed. The excipient compositions include an aqueous solution with a synergistic combination of polymers, such as, for example amylopectin, pullulan, hyaluronic acid, and tamarind xyloglucan, among others. These polymers have been demonstrated to improve the release of as well as the adhesion time of APIs onto mucosa membrane. Mucoadhesive pharmaceutical compositions that include excipient compositions include suitable APIs, such as, for example analgesics, anesthetics, anthelmintics, anti-allergic agents, anti-fungals, antihistamines, anti-inflammatory agents, antimigraine agents, and hormones, among others. Mucoadhesive pharmaceutical compositions including excipient compositions are employed in the treatment of a plurality of mucous membrane diseases.

Excipient compositions including a combination of excipients for mucoadhesive pharmaceutical compositions that improve mucoadhesiveness power, as well as release of and adhesion time of suitable active pharmaceutical ingredients (APIs) are disclosed. The excipient compositions include an aqueous solution with a synergistic combination of polymers, such as, for example amylopectin, pullulan, hyaluronic acid, and tamarind xyloglucan, among others. These polymers have been demonstrated to improve the release of as well as the adhesion time of APIs onto mucosa membrane. Mucoadhesive pharmaceutical compositions that include excipient compositions include suitable APIs, such as, for example analgesics, anesthetics, anthelmintics, anti-allergic agents, anti-fungals, antihistamines, anti-inflammatory agents, antimigraine agents, and hormones, among others. Mucoadhesive pharmaceutical compositions including excipient compositions are employed in the treatment of a plurality of mucous membrane diseases.

Disclosed herein are systems and methods for stimulating meibomian gland epithelial cell function by administering to the ocular surface or immediate vicinity of an eye of a subject an effective amount of a pharmaceutical composition containing a PLD-inducing compound, such as the cationic amphiphilic drugs (e.g. azithromycin), androgen or an androgen analogue with androgen effectiveness, corticosteroid, progesterone, IGF-1 or an IGF-1 analogue (e.g. insulin), GH, and mixtures thereof. The pharmaceutical compositions are effective to treat a variety of aliments to the eye including meibomian gland dysfunction, evaporative dry eye disease, lipid abnormalities in meibum or the tear film, and autoimmune diseases such as Sjögren's syndrome.

Disclosed herein are systems and methods for stimulating meibomian gland epithelial cell function by administering to the ocular surface or immediate vicinity of an eye of a subject an effective amount of a pharmaceutical composition containing a PLD-inducing compound, such as the cationic amphiphilic drugs (e.g. azithromycin), androgen or an androgen analogue with androgen effectiveness, corticosteroid, progesterone, IGF-1 or an IGF-1 analogue (e.g. insulin), GH, and mixtures thereof. The pharmaceutical compositions are effective to treat a variety of aliments to the eye including meibomian gland dysfunction, evaporative dry eye disease, lipid abnormalities in meibum or the tear film, and autoimmune diseases such as Sjögren's syndrome.

Disclosed are effective fixed dose oral testosterone undecanoate compositions for use in regimens without dose titration and methods for treatment of patients in need of testosterone replacement therapy. Also disclosed are criteria for continuation and discontinuation of such regimens, based on single serum T concentration levels measured at a steady state at predetermined times after initiation of said regimen and at a predetermined number of hours after administration of a morning dose of the regimen.

Disclosed are effective fixed dose oral testosterone undecanoate compositions for use in regimens without dose titration and methods for treatment of patients in need of testosterone replacement therapy. Also disclosed are criteria for continuation and discontinuation of such regimens, based on single serum T concentration levels measured at a steady state at predetermined times after initiation of said regimen and at a predetermined number of hours after administration of a morning dose of the regimen.