Buprenorphine Case Study

Development of buprenorphine as an analgesic autoinjector and its quality control parameters

4.1 Introduction

The benefit of a drug in any condition is fulfilled when it attains the therapeutic concentration in the body to reduce the symptoms or to cure diseases. To attain the therapeutic concentration, the administered drug has to be better absorbed and distributed in the body. The immediate effect produced by the drug depends upon its faster absorption and distribution. The drug delivery system also plays a role in the period of effect production (Rao et al, 2012). There are a number of drug delivery routes like oral, parenteral, inhalation, transdermal, sublingual, vaginal, ocular and rectal. Each route has its own advantage and disadvantage.

Analgesics are required to manage acute or chronic pain. The nociceptive pains are managed by non-steroidal anti-inflammatory drugs (NSAIDs). Normally pain produced during any injury in road accidents, rail accidents, tsunami, flood, terrorism and war are acute severe pain and an analgesic is required to manage them .The preferred analgesic is an opioid. Morphine, a proto type of opioid has various adverse effects like physical dependence, constipation, vomiting, respiratory depression. Among the opioids, buprenorphine is used for the development of an analgesic autoinjector which has the advantage among other opioids like better pharmacological effect, lesser physical dependence and ceiling effect of respiratory depression (Rosenblum et al,2008)

The buprenorphine hydrochloride vial was also made by M/s Neon Laboratories (Mumbai). This avoided complications in the making of buprenorphine drug cartridge. Six water filled cartridges were randomly taken for sterility test (Pharma company also certified). After completing the sterility test, 6 fresh cartridges were taken and marked. From the cartridge, 0.4 mL of water was removed under a laminar flow using a sterile disposable syringe.The weight of the cartridge was again taken and 0.4 mL of buprenorphine as buprenorphine hydrochloride was injected into the cartridge and reweighed. Each cartridge contained 0.05 mg/mL(0.3*0.4/2.35) of buprenorphine. The prepared cartridges were stored at room temperature away from dust and direct light, till