R&D Pipeline

Overview

We have developed several novel microsphere based formulations. These innovative products were formulated to increase bioavailability, thus decreasing the necessary dosage along with toxicity. This effectively allows for accurate delivery of small quantities of drugs, thereby maintaining a low and stable blood concentration of the drug within the body. The incidence and intensity of adverse effects along with dosing frequency are all lowered. Accordingly, therapeutic efficacy is boosted along with patient compliance.

Most importantly, the products have been fabricated in a scalable process--see the figures below.

Our current R&D pipeline is targeting on the following diseases:

1. Overactive Bladder (OAB):

Overactive bladder (OAB) is a chronic medical condition with characteristic symptoms of urinary urgency, frequency, and nocturia, with or without urgency incontinence, in the absence of urinary tract infection (UTI), or other obvious pathologies. It has a tremendous impact on the quality of life of both men and women, including but not limited to the performance of daily life activities, social functions, physical exercise, sleep, and sexual function. OAB affects nearly all groups of the population–most commonly patients over 40 years old--and more than 33 million adult Americans.

Oxybutynin has been widely prescribed to treat the overactive bladder for the past 40 years, however, both its oral and transdermal preparations have adverse effects. In many cases, these side effects are severe enough to cause the patients to discontinue their treatment. The Oxybutynin Microsphere Depots have controlled long-acting sustained drug release with low toxicity, little to no adverse events, and can achieve better treatment outcomes and improve patient medical compliance.

2. Parkinson’s Disease (and Restless Legs Syndrome):

Parkinson's disease is the second most common age-related neurodegenerative disease after Alzheimer's disease. More than 10 million people have this condition worldwide. It can't be cured; however, medications can help control the symptoms dramatically. 

Pramipexole is used to treat Parkinson disease. It may be used alone or in combination with other medicines (e.g., levodopa). Pramipexole is also used to treat Restless Legs Syndrome (RLS).

3. Benign prostatic hyperplasia (BPH):

Benign Prostatic Hyperplasia (BPH) is a noncancerous condition in which men’s prostate gland is enlarged. It affects about 50 percent of men between the ages of 51 and 60, and up to 90 percent of men older than 80. Approximately 30 million men have symptoms related to BPH worldwide. Tamsulosin is used to treat BPH.

The R&D pipeline and its progress are as follows:

1. A 6-week Oxybutynin Microsphere formulation (Indications: OAB and neurogenic bladder): 

The current progress: The laboratory scale-up has been completed and pilot scale-up is in progress (refer to the figures below). 

2. A 16-week Oxybutynin Microsphere formulation (Indications: OAB and neurogenic bladder): 

The current progress: Feasibility study and partial optimization completed (refer to the figures below). 

3. A 5-week Pramipexole Microsphere formulation (Indications: Parkinson’s Disease & Restless Legs Syndrome): 

The current progress: Exploratory feasibility study done (refer to the figures below). 

4. Tamsulosin Microsphere formulation (Indication: BPH): 

The current progress: Exploratory feasibility study in progress (refer to the figure below)