With the rapid development of biotechnology, peptides and protein drugs continue to emerge. At present, 35 important therapeutic drugs have been listed, and the development of biotechnology and biopharmaceutical companies is becoming increasingly global. Biotechnology drug research focuses on the development of peptides, proteins, enzymes, hormones, vaccines, cell growth factors and monoclonal antibodies that can be applied to clinical applications using DNA recombination technology. According to Parexl's Pharmaceutical R&D Statistical Source Book, 723 biotech drugs are currently undergoing FDA review (including Phase I to III clinical and FDA assessments), 700 drugs in early stages of research (pre- and pre-clinical), and More than 200 drugs have entered the final approval phase (phase III clinical and FDA assessment).
Formula introduction
The basic dosage form of biotechnological drugs is a lyophilizate. Conventional preparations, although proven to be clinically proven, have long half-lives and require long-term frequent injections, which are unacceptable problems from the perspective of the patient's psychological and economic burden.
To this end, scholars from various countries have begun to research and develop convenient and reasonable routes of administration and new preparations from two aspects: 1 implant and sustained release injection. 2 non-injectable dosage forms, such as respiratory inhalation, rectal administration, nasal, oral and transdermal administration. Injectable preparations of sustained-release biotechnological drugs are promising new dosage forms. Some varieties such as luteinizing hormone releasing hormone (LHRH) analogue microsphere injections capable of sustained release for 1 to 3 months have been put on the market. Such preparations.
The main types of peptide and protein drug sustained release preparations
The research and development of peptide and protein drug sustained-release preparations, mainly from the development process and dosage form, are mainly divided into implants and microsphere injections:
Implant, fine rod implant
The shape of the implant is a hollow micro-rod, one end is closed, the other end is open, and the bar is a non-biodegradable polymer such as polytetrafluoroethylene. A mixture of drug and silica gel (polydimethylsiloxane) is injected into the cavity.
The implant is buried under the skin of the human body, and the drug is slowly released through the opening of the silica matrix. The American Institute of Physicians (PDR) contains the implant called Norplant®, which is a drug called L-Ethyl-1-norgestrel for family planning.
The preparation has a diameter of 2.4 mm and a length of 34 mm. The doctor implants 6 thin rods on the inner side of the patient's upper arm. The drug can be released in the zero-order mode for 5 years. After the drug is released, it can be removed by surgery. .
Micro-osmotic pump implants Alza, Inc. developed a capsule-like implant in the 1970s. The preparation was implanted under the skin or other parts. The body fluid penetrated the outer shell and dissolved the interlayer electrolytic layer to laminate the volume-expanded clip. To the plastic lumen, the drug solution is released from the opening at a constant rate. There are many biomacromolecular drugs, such as insulin, heparin, nerve growth factor and other animal models for animal and body research reports.
Implants have positive implications for the treatment of chronic patients requiring long-term use, but they have the following drawbacks: 1 must be surgically implanted. 2 The formulation skeleton material is a non-biodegradable polymer, and it needs to be surgically removed after the release of the drug. 3 The preparation has irritation and discomfort in the local tissue.
Evaluation method
1, liquid chromatography
2, spectroscopy
3, electrophoresis
4. Biological activity measurement and immunoassay
The general prescription composition of the polypeptide protein drug: the currently applied protein drug injections, one type is a solvent type injection, and the other type is a lyophilized powder injection. The solvent type is easy to use, but needs to be stored at low temperatures (2-8 degrees Celsius).
Formula introduction
The basic dosage form of biotechnological drugs is a lyophilizate. Conventional preparations, although proven to be clinically proven, have long half-lives and require long-term frequent injections, which are unacceptable problems from the perspective of the patient's psychological and economic burden.
To this end, scholars from various countries have begun to research and develop convenient and reasonable routes of administration and new preparations from two aspects: 1 implant and sustained release injection. 2 non-injectable dosage forms, such as respiratory inhalation, rectal administration, nasal, oral and transdermal administration. Injectable preparations of sustained-release biotechnological drugs are promising new dosage forms. Some varieties such as luteinizing hormone releasing hormone (LHRH) analogue microsphere injections capable of sustained release for 1 to 3 months have been put on the market. Such preparations.
The main types of peptide and protein drug sustained release preparations
The research and development of peptide and protein drug sustained-release preparations, mainly from the development process and dosage form, are mainly divided into implants and microsphere injections:
Implant, fine rod implant
The shape of the implant is a hollow micro-rod, one end is closed, the other end is open, and the bar is a non-biodegradable polymer such as polytetrafluoroethylene. A mixture of drug and silica gel (polydimethylsiloxane) is injected into the cavity.
The implant is buried under the skin of the human body, and the drug is slowly released through the opening of the silica matrix. The American Institute of Physicians (PDR) contains the implant called Norplant®, which is a drug called L-Ethyl-1-norgestrel for family planning.
The preparation has a diameter of 2.4 mm and a length of 34 mm. The doctor implants 6 thin rods on the inner side of the patient's upper arm. The drug can be released in the zero-order mode for 5 years. After the drug is released, it can be removed by surgery. .
Micro-osmotic pump implants Alza, Inc. developed a capsule-like implant in the 1970s. The preparation was implanted under the skin or other parts. The body fluid penetrated the outer shell and dissolved the interlayer electrolytic layer to laminate the volume-expanded clip. To the plastic lumen, the drug solution is released from the opening at a constant rate. There are many biomacromolecular drugs, such as insulin, heparin, nerve growth factor and other animal models for animal and body research reports.
Implants have positive implications for the treatment of chronic patients requiring long-term use, but they have the following drawbacks: 1 must be surgically implanted. 2 The formulation skeleton material is a non-biodegradable polymer, and it needs to be surgically removed after the release of the drug. 3 The preparation has irritation and discomfort in the local tissue.
Evaluation method
1, liquid chromatography
2, spectroscopy
3, electrophoresis
4. Biological activity measurement and immunoassay
The general prescription composition of the polypeptide protein drug: the currently applied protein drug injections, one type is a solvent type injection, and the other type is a lyophilized powder injection. The solvent type is easy to use, but needs to be stored at low temperatures (2-8 degrees Celsius).
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