Tuesday, 01-23-2018
Bidiphar- Pharmaceutical factories have achieved GMP-WHO standard; Laboratory system has achieved GLP standard; Pharmacy Storage system has achieved GSP standard; Distribution system has achieved GDP,GPP standard; Quality management system has achieved ISO 9001: 2008; Bidiphar's products are voted as Vietnamese high-quality products by consumers for many years

Bidiphar’s research development and applications of technology in the production of drugs in cancer treatments


According to statistics on cancer in Hanoi, Ho Chi Minh City and other provinces, in our country, there are about 150.000 new cancer cases and 75.000 cancer deaths each year. Cancer is a disease that is on the rise in our country and has become the highest cause of death among non-communicable diseases. But until now, most cancer treatments are still imported and quite expensive and have yet to be produced domesticallyAccording to statistics on cancer in Hanoi, Ho Chi Minh City and other provinces, in our country, there are about 150.000 new cancer cases and 75.000 cancer deaths each year. Cancer is a disease that is on the rise in our country and has become the highest cause of death among non-communicable diseases. But until now, most cancer treatments are still imported and quite expensive and have yet to be produced domestically

In this situation, the Ministry of Health and the Ministry of Science and Technology have supported a number of research projects on cancer drugs, such as: Research on anastrozol synthesis for breast cancer treatment of the Institute of Medicine; Research on tamoxifen citrate synthesis of active ingredients, used for dosage breast cancer drug Novaldex of Institute of Biochemistry; Research extraction technology of biologically active substances from the red tree leaves and Vietnamese periwinkle for production of  anticancer drugs and export of MA. Vuong Chi Hung; Research on screening a number of pharmaceutical to isolate new substances that kill cancer cells of vice Prof. PhD Hoang ThanhHuong; Research on synthesis of Hydroxyurea treatment for cancer by vice Prof. PhD. Nguyen QuangDat; However, for many different reasons, no specific product has been produced based on these results. Therefore,  cancer treatment service still depends on import.In this situation, the Ministry of Health and the Ministry of Science and Technology have supported a number of research projects on cancer drugs, such as: Research on anastrozol synthesis for breast cancer treatment of the Institute of Medicine; Research on tamoxifen citrate synthesis of active ingredients, used for dosage breast cancer drug Novaldex of Institute of Biochemistry; Research extraction technology of biologically active substances from the red tree leaves and Vietnamese periwinkle for production of anticancer drugs and export of MA. Vuong Chi Hung; Research on screening a number of pharmaceutical to isolate new substances that kill cancer cells of vice Prof. PhD Hoang ThanhHuong; Research on synthesis of Hydroxyurea treatment for cancer by vice Prof. PhD. Nguyen QuangDat; However, for many different reasons, no specific product has been produced based on these results. Therefore,  cancer treatment service still depends on import.

Since 2008, BinhDinh Phamarceutical - Medical Equipment Company has established a group specializing in doing research and developing drugs and cancer treatment aimed at researching  and manufacturing generic injectable freeze – drying injections – that is used to treat cancer. We have gained very encouraging results as having completed 01 research and 01 state project for testing production and have been granted 13 registrations of drugs by the Ministry of Health.Since 2008, BinhDinh Phamarceutical - Medical Equipment Company has established a group specializing in doing research and developing drugs and cancer treatment aimed at researching  and manufacturing generic injectable freeze – drying injections – that is used to treat cancer. We have gained very encouraging results as having completed 01 research and 01 state project for testing production and have been granted 13 registrations of drugs by the Ministry of Health.

To achieve these results, the research team has bravely integrated and applied many technology solutions to accomplish its objectives:To achieve these results, the research team has bravely integrated and applied many technology solutions to accomplish its objectives:

Isolator technology:

Isolator technology is derived from the nuclear industry and has been used in the pharmaceutical industry since the 1980s and is now widely used in the manufacture of sterile drugs, some toxicity drugs, such as: cancer treatment, highly active drugs such as hormone ...Isolator technology is derived from the nuclear industry and has been used in the pharmaceutical industry since the 1980s and is now widely used in the manufacture of sterile drugs, some toxicity drugs, such as: cancer treatment, highly active drugs such as hormone ...

The technology of isolator production helps separate manufacturing sector with humans. The use of isolator technology is to minimize human interventions in processing areas, which can lead to reduce not only the risk of microbial contamination from the environment to sterile products but also the impact of toxic chemicals on people and production environments.The technology of isolator production helps separate manufacturing sector with humans. The use of isolator technology is to minimize human interventions in processing areas, which can lead to reduce not only the risk of microbial contamination from the environment to sterile products but also the impact of toxic chemicals on people and production environments.

Lyophilized Technology:

Lyophilizing is a process of aqueous solution which was frozen at lower temperatures than the otecti temperature of the solution. The solvent type was directly eliminated from the solid phase without going through the liquid phase under reduced pressure (usually less than 100 mmHg), then the dried product is obtained. Currently, lyophilized techniques are widely applied in manufacturing injections, eye drops and a number of other formats, such as drug delivery system used in lyophilized ophthalmology, rapid disintegration tablets, microcapsules ... as these techniques have several advantagesLyophilizing is a process of aqueous solution which was frozen at lower temperatures than the otecti temperature of the solution. The solvent type was directly eliminated from the solid phase without going through the liquid phase under reduced pressure (usually less than 100 mmHg), then the dried product is obtained. Currently, lyophilized techniques are widely applied in manufacturing injections, eye drops and a number of other formats, such as drug delivery system used in lyophilized ophthalmology, rapid disintegration tablets, microcapsules ... as these techniques have several advantages

+ Drying process is carried out at low temperature to limit the speed of chemical reactions at very low levels

+ Drying process is carried out at low temperature to limit the speed of chemical reactions at very low levels

+ Dry product obtained with high specific surface area can be dissolved quickly in need of being dissolved back.

+ Dry product obtained with high specific surface area can be dissolved quickly in need of being dissolved back.

+ Drugs are classified into dose vials before freeze-drying in aqueous solution to easily achieve the homogeneous requirements of drug content in each unit of product. So the contamination is minimized compared to other drugs jarred to vial in powder form

+ Drugs are classified into dose vials before freeze-drying in aqueous solution to easily achieve the homogeneous requirements of drug content in each unit of product. So the contamination is minimized compared to other drugs jarred to vial in powder form

+ It reduces the oxidation of drugs by limiting the presence of oxygen in the production process because the product is dried in a vacuum environment and jarred in a vacuum or under pressure of inert gas put in when the lid is replaced.

+ It reduces the oxidation of drugs by limiting the presence of oxygen in the production process because the product is dried in a vacuum environment and jarred in a vacuum or under pressure of inert gas put in when the lid is replaced.

The technology of aseptic production:

Drugs are injected directly into the patient’s body in the form of intramuscular or intravenous injection. And not only are the effects of drugs required but also the sterility and absolute safety when injections for patients must be ensured. Therefore, from design, construction of buildings, machinery and equipment investment, HVAC systems, and materials, production processes, the producers must adhere to strict rules to ensure no bacteria in the production process. The process of manufacturing sterile products must be carried out in clean areas where people, equipment and raw materials must go through airlocks. Clean areas should be maintained at an appropriate standard of cleanliness, and the air supply is filtered through a membrane filter with appropriate filter performance.Drugs are injected directly into the patient’s body in the form of intramuscular or intravenous injection. And not only are the effects of drugs required but also the sterility and absolute safety when injections for patients must be ensured. Therefore, from design, construction of buildings, machinery and equipment investment, HVAC systems, and materials, production processes, the producers must adhere to strict rules to ensure no bacteria in the production process. The process of manufacturing sterile products must be carried out in clean areas where people, equipment and raw materials must go through airlocks. Clean areas should be maintained at an appropriate standard of cleanliness, and the air supply is filtered through a membrane filter with appropriate filter performance.

So far, based on the research results achieved, BinhDinhPhamarceutical - Medical Equipment Company decided to expand the scale of production and continue to invest in research and development of cancer treatments. On 15.07.2013 the Ministry of Science and Technology approved the project 'Research and development of technology applications to produce a number of cancer drugs in BinhDinhPhamarceutical  - Medical Equipment Company and the project will begin in 2014. The project consists of 5 themes and 01 testing production project with the goal: to build and install drug production lines - lyophilized injection and lines for the production of tablets for cancer treatment with PIC / S-GMP standard, research new 12 products, complete the technology process for 6 products to improve production categories up to 25-30 drugs for cancer treatment served cure and prevention. In addition, the project will include study to produce isolator equipment dedicated to the medical establishments for drug injection.So far, based on the research results achieved, BinhDinhPhamarceutical - Medical Equipment Company decided to expand the scale of production and continue to invest in research and development of cancer treatments. On 15.07.2013 the Ministry of Science and Technology approved the project 'Research and development of technology applications to produce a number of cancer drugs in BinhDinhPhamarceutical  - Medical Equipment Company and the project will begin in 2014. The project consists of 5 themes and 01 testing production project with the goal: to build and install drug production lines - lyophilized injection and lines for the production of tablets for cancer treatment with PIC / S-GMP standard, research new 12 products, complete the technology process for 6 products to improve production categories up to 25-30 drugs for cancer treatment served cure and prevention. In addition, the project will include study to produce isolator equipment dedicated to the medical establishments for drug injection.

DRUGS OF CANCER TREATMENT PRODUCED BY BIDIPHAR:

 NO.  NAME  INGREDIENTS CONTENT
 01  BDF-FDACell 50  Fludarabin phosphat  50mg
 02  Bestdocel 80  Docetaxel  80mg/2ml
 03  Bestdocel 20  Docetaxel  20mg/0,5ml
 04  Bocartin 150  Carboplatin  150mg/15ml
 05  Bocartin 50  Carboplatin  50mg/5ml
 06  Canpaxel 100  Paclitaxel  100mg/16,67ml
 07  Canpaxel 30  Paclitaxel  30mg/5ml
 08  Etoposid Bidiphar  Etoposid  100mg/5ml
 09  Lyoxatin 100  Oxaliplatin  100mg
 10  Lyoxatin 50  Oxaliplatin  50mg
 11  Bigemax 1g  Gemcitabin  1g
 12  Bigemax 200mg  Gemcitabin 

200mg

 


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