Products

Generic Name: Nano-albumin bond paclitaxel

Paclinab is a solvent-free colloidal suspension of paclitaxel initially developed to avoid the toxicities associated with conventional paclitaxel. It contains human serum albumin-paclitaxel nanoparticles of approximately 130 nm in size, which can be infused into a vein. Upon intravenous administration, the nanoparticles dissociate rapidly into soluble albumin bound paclitaxel complexes of approximately 10 nm in size and would be transported across endothelial cells by the specific albumin receptors.

This novel formulation provided some advantages over standard paclitaxel therapy:
• Safe infusion of significantly higher doses of paclitaxel
• Shorter infusion schedules (30 minutes vs 3 hours)
• No need for premedication

Mechanism of Action:
Paclinab is a microtubule inhibitor that promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. This stability results in the inhibition of the normal dynamic reorganization of the microtubule network that is essential for vital interphase and mitotic cellular functions.

Indications:
• Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
• Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.
• Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine.
Dosage Form and Strength:
For injectable suspension: white to yellow, sterile, lyophilized powder containing 100 mg of paclitaxel formulated as albumin-bound particles in single-dose vial for reconstitution

Administration:
Intravenous infusion over 30 minutes following dilution with 20ml sterile, pyrogen free, 0.9% sodium chloride
The reconstituted Paclinab shall be administered over 30 minutes of IV infusion.

Generic Name: Palbociclib

Mechanism of Action:
Palbocap is a selective cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor. Cyclin D1 and CDK4/6 are downstream of signaling pathways, which lead to cellular proliferation.
Palbocap reduces proliferation of breast cancer cells by preventing G1 to S phase cell cycle progression.

Indications
Treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:
• An aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men
• Fulvestrant in patients with disease progression following endocrine therapy.
Dosage Form and Strengths:
Capsules: 125 mg, 100 mg, 75 mg
Supplied in HDPE bottles containing 21 capsules.
Administration
A capsule should be taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. Palbocap should be taken with food.

Generic name: Extended-release naltrexone

EXOPIO is developed by embedding naltrexone (NTX) in microspheres composed of a biodegradable copolymer, poly(d,l-lactide-co-glycolide) (PLGA), resulting in release of the active ingredient over a predetermined period. Upon injection, the microspheres begin to absorb water almost immediately, leading to a swelling of the microspheres. This process begins an initial release of the drug. As water absorption continues, the polymer begins to undergo hydrolysis. Later, physical erosion of the polymer occurs. The drug diffuses into the surrounding media as the polymer continues to undergo hydrolysis and erosion, resulting in a sustained release of the drug from the microspheres.
EXOPIO can maintain stable and pharmacologically relevant plasma concentrations of NTX for at least 30 days which leads to reduced administration frequency and improved patient compliance.
Mechanism of action
Naltrexone is a full opioid antagonist with highest affinity for the µ opioid receptors and little and no opioid activity.

Indications
Exopio is indicated for:
• Prevention of relapse to opioid dependence, following opioid detoxification

• Treatment of alcohol use disorder

Dosage form and strength
An injectable suspension containing 380 mg of naltrexone in a microsphere formulation in a single-dose vial
Supplied in a single-use kit containing:
• One vial 380 mg of Exopio microspheres
• One vial of diluent
• One 5-ml syringe
• One needle (pink color) for preparation
• Two needles (yellow color) for administration

Administration
Intramuscularly (IM) as a gluteal injection, once- monthly

Generic Name: Trastuzumab Emtansine

Trastuzumab emtansine (T-DM1) is an antibody–drug conjugate, comprised of a highly potent cytotoxic agent, DM1, connected via a stable linker to the anti-HER2 antibody, trastuzumab, thereby primarily targeting chemotherapy delivery to cells overexpressing the HER2 receptor while minimizing the systemic exposure.

Mechanism of Action:
Upon binding to sub-domain IV of the HER2 receptor, PADYNEX undergoes receptor-mediated internalization and subsequent lysosomal degradation, resulting in intracellular release of DM1-containing cytotoxic catabolites. Binding of DM1 to tubulin disrupts microtubule networks in the cell, which results in cell cycle arrest and apoptotic cell death.

Indications
PADYNEX indicated, as a single agent, for:
• Treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either:
• received prior therapy for metastatic disease,
• developed disease recurrence during or within six months of completing adjuvant therapy
• Adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.

Dosage form and strengths:
Lyophilized powder in single-dose vials: 100 mg, 160 mg

Administration
After reconstitution and dilution, PADYNEX should be administered as an intravenous infusion only with a 0.2 or 0.22 micron in-line polyethersulfone (PES) filter in 30 to 90 minutes.

Generic name: Extended-release buprenorphine

Extended-release buprenorphine is an injectable formulation that uses in-situ gel forming technology to release buprenorphine at a controlled rate over a one-month period. It is injected by a treatment provider as a liquid and, once inside the body, turns to a solid gel called a depot. The depot gradually releases buprenorphine at a controlled rate, providing a constant blood level of drug throughout the month.

Mechanism of action
Buprenorphine is a mu-opioid receptor partial agonist and a kappa-opioid receptor antagonist.

Indication
Treatment of moderate to severe opioid use disorder

Dosage form and strengths
Prefilled syringe: 100 mg/0.5 mL and 300 mg/1.5 mL

Administration
Extended-release buprenorphine should be administered monthly only by subcutaneous injection in the abdominal region.

Generic name: Triamcinolone acetonide extended-release
Depostiva is a novel, extended-release, microsphere-based formulation of triamcinolone acetonide (TA) embedded in a biodegradable poly lactic-co-glycolic acid (PLGA) matrix.
After intra-articular injection of Depostiva, biodegradation of PLGA microspheres begins with the formation of small channels on their surface. These small channels allow slow drug release and extend residence time of triamcinolone acetonide (TA) in the synovial fluid up to 12 weeks.
Mechanism of Action
Triamcinolone acetonide is a corticosteroid with anti-inflammatory and immunomodulating properties. It binds to and activates the glucocorticoid receptor, leading to activation of anti-inflammatory transcription factors and inhibition of inflammatory transduction pathways.
Indication
Management of osteoarthritis pain of the knee
Dosage form and strength
Intra-articular injectable suspension that delivers 32 mg of triamcinolone acetonide supplied as a single-dose kit containing one vial of Depostiva microsphere powder and one vial of 5 mL diluent.
Administration
Intra-articular injection only

Generic name: Remdesivir

Mechanism of action
Remdesivir is a broad-spectrum antiviral drug that inhibits SARS-CoV-2 RNA-dependent RNA polymerase (RdRp), which is essential for viral replication.

Indication
Treatment of hospitalized or non-hospitalized patients with mild to moderate COVID-19 at high risk for progression to severe COVID-19

Dosage form and strength
Concentrate for solution for Injection: 100 mg/20 mL (5 mg/mL)
Supplied as a single-dose vial

Administration
Intravenous infusion following dilution in sterile, pyrogen free, 0.9% sodium chloride.